Associate Director Clinical Quality Assurance Jobs
Associate Director Clinical Quality Assurance jobs are open across biopharma, medical devices, contract research organizations, and health systems, from senior manager to VP level, with specializations in GCP oversight, regulatory submissions, and CAPA management. Scan the live roles below and apply to whichever ones fit.
Find JobsOverview
Open roles52
Top stateCalifornia
Top employerACES ABA
Top citySan Diego, CA
Work type34% Remote
Top industryBiotechnology
Showing 4 of 52+ Associate Director Clinical Quality Assurance jobs
Senior Director, Global Clinical Supply Quality Assurance
We won't show you this job again
New 17h ago
Daiichi Sankyo
Senior Director, Global Clinical Supply Quality Assurance
Basking Ridge, New Jersey
New 17h ago
N
In-Office Clinical QA / Oasis Review Specialist
We won't show you this job again
N
Added 3d ago
Newline Home Health & Pallative Care
In-Office Clinical QA / Oasis Review Specialist
Colton, California
Added 3d ago
Clinical QA Nurse Specialist
We won't show you this job again
Added 4d ago
Vida Health
Clinical QA Nurse Specialist
Remote
Added 4d ago
RN Clinical Operations Quality Assurance Improvement Case Management
We won't show you this job again
Added 4d ago
MedStar Health
RN Clinical Operations Quality Assurance Improvement Case Management
Columbia, Maryland
Added 4d ago
New 17h ago
Senior Director, Global Clinical Supply Quality Assurance
Daiichi Sankyo·Basking Ridge, New Jersey
Job functions:
$210k - $350k/yr
Bachelor's degree
10,000+ employees
Job Description
Job Title: Senior Director, Global Clinical Supply Quality Assurance
Job Requisition ID: 2456
Posting Start Date: 10/26/26
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary
The Senior Director, Quality Assurance, Global Clinical Supply is responsible for establishing and leading the global quality strategy for clinical trial materials across all phases of development. This role ensures compliance with global regulatory requirements, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP), while driving quality excellence throughout the CTM lifecycle—from manufacturing and packaging to distribution and use in clinical trials.
Responsibilities
Strategic Leadership & Oversight and Cross-Functional Team Participation:
Cross-Functional Team Participation: Develop, lead, participate or manage resources that support various working groups Responsible to contribute to the achievement of global QA vision and enhance globalization at DS QA-GMP affiliates, proactively support and contribute to the development and execution of regional and global QA GMP strategies, internal and external collaboration, activities and initiatives that support and drive compliance and improvement opportunities for IMP, new and established products; Ensure a strong interface with Pharmaceutical Technical Development, CSO, RACMC to ensure full QA visibility and proactive engagement of QA across stakeholder
Responsible for providing strategic QA GMP leadership and oversight for clinical trial material (CTM) lifecycle management (e.g. supplier and material management, labeling, shelf-life management, packaging, distribution, and destruction) to ensure investigational products are safe, consistent, and traceable.
Development of Standards and Procedures (SOPs): Liaise with GMP Quality Systems function to ensure adequate procedural documents directly impacting area of responsible and/ or other GMP areas as assigned. May lead and/ or direct key global/regional QA GMP Standards, Procedures and Instructions. Develop, implement, and maintain a global CTM quality assurance program aligned with organizational and regulatory expectations.
Partner closely with relevant stakeholders across various departments (includes but not limited to clinical supply chain, clinical operations, regulatory, R&D QA, and GMP QA) responsible for various activities in the management of clinical trial materials.
Establish strong working relationships with Clinical Supplies Organization (CSO) to ensure clinical forecasts reflect shared, achievable targets for QA GMP and align with the broader clinical development plans.
Serve as the subject matter expert (SME) for CTM quality across regions.
May represent QA GMP Head in leadership meetings to communicate, deliver and / or execute the vision and strategy of GMP-QA organization. Communicate clearly and in a timely manner with Regional and Global QA organization and local leaders of DS QA-GMP affiliates to address and identify proactive solution for business contribution, ability to effectively manage conflict with diplomacy. Ensure effective influential skills to support the vision and strategy of Global QA mission across boundaries and with different stakeholders.
Directs and oversees the local process for investigation of commercial and investigational drug product complaints. Assures that all product quality complaints are properly documented and investigated in accordance with GMP and Daiichi Sankyo global and internal SOP requirements. Accountable to ensure adequate resources is in place to manage recall decisions for commercial and investigational drug products. Directs and administers recall operation throughout QA and related functions.
Regulatory Compliance and Inspection Readiness:
Maintain inspection readiness and lead responses to regulatory inspections and audits for CTM related activities.
Ensure compliance of clinical labeling with protocol and country-specific requirements.
Ensure appropriate controls are in place to ensure randomization and blinding integrity.
Provide QA guidance for clinical protocols, regulatory dossiers and applications (e.g. IND, investigational medicinal product dossiers (IMPDs, Clinical Trial Applications), and clinical inquiries (e.g. Contract Research Organizations, clinical institutions, pharmacies, Medical Affairs, IRB, EC, etc)
Oversee quality systems related to CTM (deviations, CAPA, change control, risk management).
Responsibilities Continued
Drug Product Release and Oversight of Clinical Trial Materials Lifecycle:
Drug Product Release: Exercise leadership in order to execute a comprehensive drug product release program for commercial and investigational drug products and assures that all external contractors involved in manufacturing and testing provide GMP compliant release documentation ensuring satisfactory QA review and approval of drug product master production records.
Ensure proactive planning and forecasting for IMP relevant activities and QA review process as necessary. Support the implementation of related change controls and provide the necessary assessment to ensure that all changes are properly implemented in accordance with regulatory requirements.
Ensure QA teams are fit for purpose to deliver against projected milestones and on time batch review and release process are in place and as per pre-defined procedure.
Ensure Stakeholder management and engagement in order to facilitate effective QA engagement across commercial, CMOs and IMP deliverables.
Responsible for developing a CSO/GMP CTM lifecycle strategy for existing and future global clinical studies to ensure appropriate resourcing and execution.
Responsible for ensuring CTM activities adhere to GMP and Good Distribution Practice (GDP) from manufacturer to clinical subject per defined clinical timelines and expectations.
Support Product Release Management activities to ensure CTM disposition (including QP declaration and release) complies with company and regulatory requirements
Ensure clinical supply planning is shared with QA GMP to ensure disposition activities support clinical development timelines.
Contract Manufacturing Management:
Contract Manufacturer Organization (CMO) Management: Ensure oversight of outsourced GMP activities provided by contract manufacturing / lab / warehousing organizations and manages the ervices provided by these entities in order to ensure the GMP compliance level expected as per applicable regulation and DS QA Global Standards/ guidelines. Ensures the compliance level for these organizations in order to maintain readiness for regulatory inspections and the compliance with local and global markets.
Liaises with regulatory agencies and internally on GMP QA issues.
Work as a cross functional partner to the internal business stakeholders overseeing QA activities for the development of new products or services provided by these organizations.Provide support in the qualification, auditing, and performance management of CMOs, depots, and suppliers associated with CTM activities.
Ensure third-party compliance with quality agreements and regulatory requirements.
Responsible for providing quality leadership for E2E clinical inspection readiness activities for CTM
Oversee and ensure CTM compliance with global regulations (e.g., FDA, EMA, ICH guidelines) as appropriate.
Qualifications
Education Qualifications
Bachelor's Degree in Life Sciences, Pharmacy, Chemistry, or related field is required, An advanced degree (MS, PhD, PharmD) preferred
Experience Qualifications
10 or more years of professional experience in Quality Assurance within biotech or pharmaceutical environments. required
Strong experience supporting clinical trial materials and clinical supply chains. Demonstrated ability to operate independently and build systems from the ground up. Prior experience working in a matrixed environment is a must. required
Travel Requirements
Ability to travel up to 20% of the time.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range:
USD$209,850.00 - USD$349,750.00
Download Our Benefits Summary PDF
Professionals
Job Requisition ID: 2456
Posting Start Date: 10/26/26
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary
The Senior Director, Quality Assurance, Global Clinical Supply is responsible for establishing and leading the global quality strategy for clinical trial materials across all phases of development. This role ensures compliance with global regulatory requirements, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP), while driving quality excellence throughout the CTM lifecycle—from manufacturing and packaging to distribution and use in clinical trials.
Responsibilities
Strategic Leadership & Oversight and Cross-Functional Team Participation:
Cross-Functional Team Participation: Develop, lead, participate or manage resources that support various working groups Responsible to contribute to the achievement of global QA vision and enhance globalization at DS QA-GMP affiliates, proactively support and contribute to the development and execution of regional and global QA GMP strategies, internal and external collaboration, activities and initiatives that support and drive compliance and improvement opportunities for IMP, new and established products; Ensure a strong interface with Pharmaceutical Technical Development, CSO, RACMC to ensure full QA visibility and proactive engagement of QA across stakeholder
Responsible for providing strategic QA GMP leadership and oversight for clinical trial material (CTM) lifecycle management (e.g. supplier and material management, labeling, shelf-life management, packaging, distribution, and destruction) to ensure investigational products are safe, consistent, and traceable.
Development of Standards and Procedures (SOPs): Liaise with GMP Quality Systems function to ensure adequate procedural documents directly impacting area of responsible and/ or other GMP areas as assigned. May lead and/ or direct key global/regional QA GMP Standards, Procedures and Instructions. Develop, implement, and maintain a global CTM quality assurance program aligned with organizational and regulatory expectations.
Partner closely with relevant stakeholders across various departments (includes but not limited to clinical supply chain, clinical operations, regulatory, R&D QA, and GMP QA) responsible for various activities in the management of clinical trial materials.
Establish strong working relationships with Clinical Supplies Organization (CSO) to ensure clinical forecasts reflect shared, achievable targets for QA GMP and align with the broader clinical development plans.
Serve as the subject matter expert (SME) for CTM quality across regions.
May represent QA GMP Head in leadership meetings to communicate, deliver and / or execute the vision and strategy of GMP-QA organization. Communicate clearly and in a timely manner with Regional and Global QA organization and local leaders of DS QA-GMP affiliates to address and identify proactive solution for business contribution, ability to effectively manage conflict with diplomacy. Ensure effective influential skills to support the vision and strategy of Global QA mission across boundaries and with different stakeholders.
Directs and oversees the local process for investigation of commercial and investigational drug product complaints. Assures that all product quality complaints are properly documented and investigated in accordance with GMP and Daiichi Sankyo global and internal SOP requirements. Accountable to ensure adequate resources is in place to manage recall decisions for commercial and investigational drug products. Directs and administers recall operation throughout QA and related functions.
Regulatory Compliance and Inspection Readiness:
Maintain inspection readiness and lead responses to regulatory inspections and audits for CTM related activities.
Ensure compliance of clinical labeling with protocol and country-specific requirements.
Ensure appropriate controls are in place to ensure randomization and blinding integrity.
Provide QA guidance for clinical protocols, regulatory dossiers and applications (e.g. IND, investigational medicinal product dossiers (IMPDs, Clinical Trial Applications), and clinical inquiries (e.g. Contract Research Organizations, clinical institutions, pharmacies, Medical Affairs, IRB, EC, etc)
Oversee quality systems related to CTM (deviations, CAPA, change control, risk management).
Responsibilities Continued
Drug Product Release and Oversight of Clinical Trial Materials Lifecycle:
Drug Product Release: Exercise leadership in order to execute a comprehensive drug product release program for commercial and investigational drug products and assures that all external contractors involved in manufacturing and testing provide GMP compliant release documentation ensuring satisfactory QA review and approval of drug product master production records.
Ensure proactive planning and forecasting for IMP relevant activities and QA review process as necessary. Support the implementation of related change controls and provide the necessary assessment to ensure that all changes are properly implemented in accordance with regulatory requirements.
Ensure QA teams are fit for purpose to deliver against projected milestones and on time batch review and release process are in place and as per pre-defined procedure.
Ensure Stakeholder management and engagement in order to facilitate effective QA engagement across commercial, CMOs and IMP deliverables.
Responsible for developing a CSO/GMP CTM lifecycle strategy for existing and future global clinical studies to ensure appropriate resourcing and execution.
Responsible for ensuring CTM activities adhere to GMP and Good Distribution Practice (GDP) from manufacturer to clinical subject per defined clinical timelines and expectations.
Support Product Release Management activities to ensure CTM disposition (including QP declaration and release) complies with company and regulatory requirements
Ensure clinical supply planning is shared with QA GMP to ensure disposition activities support clinical development timelines.
Contract Manufacturing Management:
Contract Manufacturer Organization (CMO) Management: Ensure oversight of outsourced GMP activities provided by contract manufacturing / lab / warehousing organizations and manages the ervices provided by these entities in order to ensure the GMP compliance level expected as per applicable regulation and DS QA Global Standards/ guidelines. Ensures the compliance level for these organizations in order to maintain readiness for regulatory inspections and the compliance with local and global markets.
Liaises with regulatory agencies and internally on GMP QA issues.
Work as a cross functional partner to the internal business stakeholders overseeing QA activities for the development of new products or services provided by these organizations.Provide support in the qualification, auditing, and performance management of CMOs, depots, and suppliers associated with CTM activities.
Ensure third-party compliance with quality agreements and regulatory requirements.
Responsible for providing quality leadership for E2E clinical inspection readiness activities for CTM
Oversee and ensure CTM compliance with global regulations (e.g., FDA, EMA, ICH guidelines) as appropriate.
Qualifications
Education Qualifications
Bachelor's Degree in Life Sciences, Pharmacy, Chemistry, or related field is required, An advanced degree (MS, PhD, PharmD) preferred
Experience Qualifications
10 or more years of professional experience in Quality Assurance within biotech or pharmaceutical environments. required
Strong experience supporting clinical trial materials and clinical supply chains. Demonstrated ability to operate independently and build systems from the ground up. Prior experience working in a matrixed environment is a must. required
Travel Requirements
Ability to travel up to 20% of the time.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range:
USD$209,850.00 - USD$349,750.00
Download Our Benefits Summary PDF
Professionals
Daiichi Sankyo
Senior Director, Global Clinical Supply Quality Assurance
Basking Ridge, New Jersey
New 17h ago10,000+ employees
Job functions:
$210k - $350k/yr
Bachelor's degree
Job Description
Job Title: Senior Director, Global Clinical Supply Quality Assurance
Job Requisition ID: 2456
Posting Start Date: 10/26/26
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary
The Senior Director, Quality Assurance, Global Clinical Supply is responsible for establishing and leading the global quality strategy for clinical trial materials across all phases of development. This role ensures compliance with global regulatory requirements, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP), while driving quality excellence throughout the CTM lifecycle—from manufacturing and packaging to distribution and use in clinical trials.
Responsibilities
Strategic Leadership & Oversight and Cross-Functional Team Participation:
Cross-Functional Team Participation: Develop, lead, participate or manage resources that support various working groups Responsible to contribute to the achievement of global QA vision and enhance globalization at DS QA-GMP affiliates, proactively support and contribute to the development and execution of regional and global QA GMP strategies, internal and external collaboration, activities and initiatives that support and drive compliance and improvement opportunities for IMP, new and established products; Ensure a strong interface with Pharmaceutical Technical Development, CSO, RACMC to ensure full QA visibility and proactive engagement of QA across stakeholder
Responsible for providing strategic QA GMP leadership and oversight for clinical trial material (CTM) lifecycle management (e.g. supplier and material management, labeling, shelf-life management, packaging, distribution, and destruction) to ensure investigational products are safe, consistent, and traceable.
Development of Standards and Procedures (SOPs): Liaise with GMP Quality Systems function to ensure adequate procedural documents directly impacting area of responsible and/ or other GMP areas as assigned. May lead and/ or direct key global/regional QA GMP Standards, Procedures and Instructions. Develop, implement, and maintain a global CTM quality assurance program aligned with organizational and regulatory expectations.
Partner closely with relevant stakeholders across various departments (includes but not limited to clinical supply chain, clinical operations, regulatory, R&D QA, and GMP QA) responsible for various activities in the management of clinical trial materials.
Establish strong working relationships with Clinical Supplies Organization (CSO) to ensure clinical forecasts reflect shared, achievable targets for QA GMP and align with the broader clinical development plans.
Serve as the subject matter expert (SME) for CTM quality across regions.
May represent QA GMP Head in leadership meetings to communicate, deliver and / or execute the vision and strategy of GMP-QA organization. Communicate clearly and in a timely manner with Regional and Global QA organization and local leaders of DS QA-GMP affiliates to address and identify proactive solution for business contribution, ability to effectively manage conflict with diplomacy. Ensure effective influential skills to support the vision and strategy of Global QA mission across boundaries and with different stakeholders.
Directs and oversees the local process for investigation of commercial and investigational drug product complaints. Assures that all product quality complaints are properly documented and investigated in accordance with GMP and Daiichi Sankyo global and internal SOP requirements. Accountable to ensure adequate resources is in place to manage recall decisions for commercial and investigational drug products. Directs and administers recall operation throughout QA and related functions.
Regulatory Compliance and Inspection Readiness:
Maintain inspection readiness and lead responses to regulatory inspections and audits for CTM related activities.
Ensure compliance of clinical labeling with protocol and country-specific requirements.
Ensure appropriate controls are in place to ensure randomization and blinding integrity.
Provide QA guidance for clinical protocols, regulatory dossiers and applications (e.g. IND, investigational medicinal product dossiers (IMPDs, Clinical Trial Applications), and clinical inquiries (e.g. Contract Research Organizations, clinical institutions, pharmacies, Medical Affairs, IRB, EC, etc)
Oversee quality systems related to CTM (deviations, CAPA, change control, risk management).
Responsibilities Continued
Drug Product Release and Oversight of Clinical Trial Materials Lifecycle:
Drug Product Release: Exercise leadership in order to execute a comprehensive drug product release program for commercial and investigational drug products and assures that all external contractors involved in manufacturing and testing provide GMP compliant release documentation ensuring satisfactory QA review and approval of drug product master production records.
Ensure proactive planning and forecasting for IMP relevant activities and QA review process as necessary. Support the implementation of related change controls and provide the necessary assessment to ensure that all changes are properly implemented in accordance with regulatory requirements.
Ensure QA teams are fit for purpose to deliver against projected milestones and on time batch review and release process are in place and as per pre-defined procedure.
Ensure Stakeholder management and engagement in order to facilitate effective QA engagement across commercial, CMOs and IMP deliverables.
Responsible for developing a CSO/GMP CTM lifecycle strategy for existing and future global clinical studies to ensure appropriate resourcing and execution.
Responsible for ensuring CTM activities adhere to GMP and Good Distribution Practice (GDP) from manufacturer to clinical subject per defined clinical timelines and expectations.
Support Product Release Management activities to ensure CTM disposition (including QP declaration and release) complies with company and regulatory requirements
Ensure clinical supply planning is shared with QA GMP to ensure disposition activities support clinical development timelines.
Contract Manufacturing Management:
Contract Manufacturer Organization (CMO) Management: Ensure oversight of outsourced GMP activities provided by contract manufacturing / lab / warehousing organizations and manages the ervices provided by these entities in order to ensure the GMP compliance level expected as per applicable regulation and DS QA Global Standards/ guidelines. Ensures the compliance level for these organizations in order to maintain readiness for regulatory inspections and the compliance with local and global markets.
Liaises with regulatory agencies and internally on GMP QA issues.
Work as a cross functional partner to the internal business stakeholders overseeing QA activities for the development of new products or services provided by these organizations.Provide support in the qualification, auditing, and performance management of CMOs, depots, and suppliers associated with CTM activities.
Ensure third-party compliance with quality agreements and regulatory requirements.
Responsible for providing quality leadership for E2E clinical inspection readiness activities for CTM
Oversee and ensure CTM compliance with global regulations (e.g., FDA, EMA, ICH guidelines) as appropriate.
Qualifications
Education Qualifications
Bachelor's Degree in Life Sciences, Pharmacy, Chemistry, or related field is required, An advanced degree (MS, PhD, PharmD) preferred
Experience Qualifications
10 or more years of professional experience in Quality Assurance within biotech or pharmaceutical environments. required
Strong experience supporting clinical trial materials and clinical supply chains. Demonstrated ability to operate independently and build systems from the ground up. Prior experience working in a matrixed environment is a must. required
Travel Requirements
Ability to travel up to 20% of the time.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range:
USD$209,850.00 - USD$349,750.00
Download Our Benefits Summary PDF
Professionals
Job Requisition ID: 2456
Posting Start Date: 10/26/26
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary
The Senior Director, Quality Assurance, Global Clinical Supply is responsible for establishing and leading the global quality strategy for clinical trial materials across all phases of development. This role ensures compliance with global regulatory requirements, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP), while driving quality excellence throughout the CTM lifecycle—from manufacturing and packaging to distribution and use in clinical trials.
Responsibilities
Strategic Leadership & Oversight and Cross-Functional Team Participation:
Cross-Functional Team Participation: Develop, lead, participate or manage resources that support various working groups Responsible to contribute to the achievement of global QA vision and enhance globalization at DS QA-GMP affiliates, proactively support and contribute to the development and execution of regional and global QA GMP strategies, internal and external collaboration, activities and initiatives that support and drive compliance and improvement opportunities for IMP, new and established products; Ensure a strong interface with Pharmaceutical Technical Development, CSO, RACMC to ensure full QA visibility and proactive engagement of QA across stakeholder
Responsible for providing strategic QA GMP leadership and oversight for clinical trial material (CTM) lifecycle management (e.g. supplier and material management, labeling, shelf-life management, packaging, distribution, and destruction) to ensure investigational products are safe, consistent, and traceable.
Development of Standards and Procedures (SOPs): Liaise with GMP Quality Systems function to ensure adequate procedural documents directly impacting area of responsible and/ or other GMP areas as assigned. May lead and/ or direct key global/regional QA GMP Standards, Procedures and Instructions. Develop, implement, and maintain a global CTM quality assurance program aligned with organizational and regulatory expectations.
Partner closely with relevant stakeholders across various departments (includes but not limited to clinical supply chain, clinical operations, regulatory, R&D QA, and GMP QA) responsible for various activities in the management of clinical trial materials.
Establish strong working relationships with Clinical Supplies Organization (CSO) to ensure clinical forecasts reflect shared, achievable targets for QA GMP and align with the broader clinical development plans.
Serve as the subject matter expert (SME) for CTM quality across regions.
May represent QA GMP Head in leadership meetings to communicate, deliver and / or execute the vision and strategy of GMP-QA organization. Communicate clearly and in a timely manner with Regional and Global QA organization and local leaders of DS QA-GMP affiliates to address and identify proactive solution for business contribution, ability to effectively manage conflict with diplomacy. Ensure effective influential skills to support the vision and strategy of Global QA mission across boundaries and with different stakeholders.
Directs and oversees the local process for investigation of commercial and investigational drug product complaints. Assures that all product quality complaints are properly documented and investigated in accordance with GMP and Daiichi Sankyo global and internal SOP requirements. Accountable to ensure adequate resources is in place to manage recall decisions for commercial and investigational drug products. Directs and administers recall operation throughout QA and related functions.
Regulatory Compliance and Inspection Readiness:
Maintain inspection readiness and lead responses to regulatory inspections and audits for CTM related activities.
Ensure compliance of clinical labeling with protocol and country-specific requirements.
Ensure appropriate controls are in place to ensure randomization and blinding integrity.
Provide QA guidance for clinical protocols, regulatory dossiers and applications (e.g. IND, investigational medicinal product dossiers (IMPDs, Clinical Trial Applications), and clinical inquiries (e.g. Contract Research Organizations, clinical institutions, pharmacies, Medical Affairs, IRB, EC, etc)
Oversee quality systems related to CTM (deviations, CAPA, change control, risk management).
Responsibilities Continued
Drug Product Release and Oversight of Clinical Trial Materials Lifecycle:
Drug Product Release: Exercise leadership in order to execute a comprehensive drug product release program for commercial and investigational drug products and assures that all external contractors involved in manufacturing and testing provide GMP compliant release documentation ensuring satisfactory QA review and approval of drug product master production records.
Ensure proactive planning and forecasting for IMP relevant activities and QA review process as necessary. Support the implementation of related change controls and provide the necessary assessment to ensure that all changes are properly implemented in accordance with regulatory requirements.
Ensure QA teams are fit for purpose to deliver against projected milestones and on time batch review and release process are in place and as per pre-defined procedure.
Ensure Stakeholder management and engagement in order to facilitate effective QA engagement across commercial, CMOs and IMP deliverables.
Responsible for developing a CSO/GMP CTM lifecycle strategy for existing and future global clinical studies to ensure appropriate resourcing and execution.
Responsible for ensuring CTM activities adhere to GMP and Good Distribution Practice (GDP) from manufacturer to clinical subject per defined clinical timelines and expectations.
Support Product Release Management activities to ensure CTM disposition (including QP declaration and release) complies with company and regulatory requirements
Ensure clinical supply planning is shared with QA GMP to ensure disposition activities support clinical development timelines.
Contract Manufacturing Management:
Contract Manufacturer Organization (CMO) Management: Ensure oversight of outsourced GMP activities provided by contract manufacturing / lab / warehousing organizations and manages the ervices provided by these entities in order to ensure the GMP compliance level expected as per applicable regulation and DS QA Global Standards/ guidelines. Ensures the compliance level for these organizations in order to maintain readiness for regulatory inspections and the compliance with local and global markets.
Liaises with regulatory agencies and internally on GMP QA issues.
Work as a cross functional partner to the internal business stakeholders overseeing QA activities for the development of new products or services provided by these organizations.Provide support in the qualification, auditing, and performance management of CMOs, depots, and suppliers associated with CTM activities.
Ensure third-party compliance with quality agreements and regulatory requirements.
Responsible for providing quality leadership for E2E clinical inspection readiness activities for CTM
Oversee and ensure CTM compliance with global regulations (e.g., FDA, EMA, ICH guidelines) as appropriate.
Qualifications
Education Qualifications
Bachelor's Degree in Life Sciences, Pharmacy, Chemistry, or related field is required, An advanced degree (MS, PhD, PharmD) preferred
Experience Qualifications
10 or more years of professional experience in Quality Assurance within biotech or pharmaceutical environments. required
Strong experience supporting clinical trial materials and clinical supply chains. Demonstrated ability to operate independently and build systems from the ground up. Prior experience working in a matrixed environment is a must. required
Travel Requirements
Ability to travel up to 20% of the time.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range:
USD$209,850.00 - USD$349,750.00
Download Our Benefits Summary PDF
Professionals
Associate Director Clinical Quality Assurance Jobs by Experience Level
See All 52 Associate Director Clinical Quality Assurance Jobs
Find roles that match your experience and apply in just a few clicks.
Find JobsAssociate Director Clinical Quality Assurance Job Market
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
- Healthcare & Medical Services
- Consulting & Professional Services
- Education
- Food & Beverage
What Employers Look For
The qualifications that appear most often in associate director clinical quality assurance jobs.
- Bachelor's degree in life sciences plus at least eight years of clinical quality assurance experience
- Direct experience with FDA GCP regulations, ICH E6 guidelines, and 21 CFR Part 11 compliance
- Demonstrated leadership of internal and vendor audits across clinical trial phases
- Hands-on CAPA management including root cause analysis and effectiveness verification
- Experience supporting or preparing for FDA, EMA, or other regulatory inspections
- Proficiency with electronic quality management systems such as Veeva Vault QualityDocs or TrackWise
Tips for Your Associate Director Clinical Quality Assurance Job Search
Tailor your resume to GCP audit depth
Hiring managers at this level want to see the scope of your audit programs, not just that you've conducted audits. Quantify the number of sites audited, therapeutic areas covered, and any inspection readiness work you led for FDA or EMA reviews.
Highlight CAPA ownership across the lifecycle
Many candidates list CAPA experience but don't show closure rates or systemic issue resolution. Describe specific CAPA programs you owned from root cause analysis through effectiveness checks, especially cases tied to a Warning Letter or 483 response.
Apply early to roles that fit
Migrate Mate lists associate director clinical quality assurance openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Target postings by development phase focus
Job descriptions for this role vary significantly depending on whether the company runs Phase I through IV trials or focuses on a single phase. Filter your search by pipeline stage so your application materials align with the sponsor's actual trial complexity and regulatory exposure.
Prepare a case study for your panel interview
Panel interviews for this role routinely include a hypothetical: a critical audit finding, a SOP gap, or a data integrity issue. Walk the hiring team through how you identified the problem, escalated appropriately, and drove resolution without using the word 'ensured.'
Negotiate scope into your offer discussion
Beyond compensation, confirm whether the role includes direct oversight of QA staff, vendor qualification authority, and executive reporting lines. These structural details affect your actual decision-making power and should be clarified before you accept any offer.
Associate Director Clinical Quality Assurance Jobs: Frequently Asked Questions
Which companies are hiring the most associate director clinical quality assurances?
The most active employers for associate director clinical quality assurances right now are ACES ABA, Arcus Biosciences, and AbbVie, and the most openings are in California, New Jersey, and Massachusetts, based on current listings on Migrate Mate as of October 2026. Biopharma sponsors and large contract research organizations tend to post the highest volume of these roles.
How many associate director clinical quality assurance jobs are remote?
About 66% of associate director clinical quality assurance openings are fully remote or hybrid as of October 2026, making it one of the more flexible director-level clinical roles. Remote opportunities are most concentrated in GCP oversight, SOP governance, and inspection readiness functions where on-site presence at a manufacturing facility is not required.
How do you become an associate director clinical quality assurance?
Most professionals reach this level by building a foundation in clinical operations or quality assurance at a sponsor or CRO, then progressively taking on audit program ownership, direct reports, and cross-functional project leadership. Gaining hands-on experience with regulatory inspections, CAPA governance, and vendor qualification strengthens the transition from senior manager to associate director, and a certification such as RQAP-GCP or ASQ CQA can reinforce your credentials.
Can you get an associate director clinical quality assurance role with limited leadership experience?
Moving into this role without prior people management is possible if you can demonstrate equivalent accountability, such as leading a QA workstream, managing vendor oversight programs, or serving as the primary QA contact on a registration trial. Employers hiring from contributor roles typically look for a clear record of cross-functional influence and the ability to present quality risk assessments to senior stakeholders independently.
What does the associate director clinical quality assurance interview process look like?
The process typically begins with a recruiter screen focused on your audit background and regulatory exposure, followed by a hiring manager conversation that digs into specific inspection or CAPA scenarios you've handled. Later rounds usually involve a panel with clinical operations, regulatory affairs, or VP-level quality leadership, and many companies include a case study or presentation component where you walk through how you'd address a quality event or build out an audit plan.
Where can I find and apply to associate director clinical quality assurance jobs?
You can find and apply to associate director clinical quality assurance jobs on Migrate Mate, which lists current openings from across the United States. Search the available roles, find the ones that match your background and target companies, and apply directly to each listing that fits.
See All 52 Associate Director Clinical Quality Assurance Jobs
Find roles that match your experience and apply in just a few clicks.
Find Jobs