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.
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The Senior Manager, Clinical Quality Assurance is responsible for working with study management teams to facilitate internal and external adherence to Quality and Regulatory Compliance by ensuring conformance to domestic and international quality regulations and GCP guidelines. The role is accountable for participating in day-to-day QA Compliance operations in conformance with Arcus Biosciences processes and procedures.
This position supports the Clinical Quality Assurance function by providing GCP compliance oversight and support to Arcus Clinical Development therapeutic areas. A key activity of the role is providing expertise and guidance regarding applicable regulatory, Good Clinical Practice, and Arcus Standard Operating Procedure requirements for the conduct of clinical studies. Responsibilities also include inspection readiness planning, management of health authority inspections and audits by external development partners, management of clinical audit programs, and oversight of consultant auditors. This role will lead audits of investigator sites, internal functional/process audits, and audits of clinical vendors (GCP, GCLP, GPvP).
Responsibilities
- Support clinical study teams as a core team member for assigned studies through attendance at study management team meetings, review of study documents, and QA consultation on GCP-related questions
- Identify and escalate serious non-compliance issues to Clinical QA and Quality group leadership, including the assessment of serious breaches
- Maintain a high level of expertise in global GCP regulations and internal policies and procedures that impact clinical study conduct
- Clinical QA point of contact for specific clinical functional areas to support study and non-study specific projects
- Support the management of study-specific deviations/events/CAPAs in the GCP/PV space
- Collaborate with CRO quality counterparts as delegated, including participation in QA-QA meetings
- Participate in internal and external GCP audits as assigned in support of the execution of the audit programs and support the management of audit lifecycle activities as assigned, such as scheduling planning, issuing agendas, audit execution, issuing reports evaluating responses, requesting clarification, issuing CAPA, and audit closing
- Maintain up to date audit execution results in Arcus electronic quality management system (Veeva Quality Vault, preferred) and report compliance trends based on internal / external regulatory observations to ensure business continuity
- Clearly present audit findings and/or other related audit information to appropriate departmental personnel, as required
- Work directly with auditees to ensure completion of corrective and preventative actions to address compliance concerns identified during audits
- Support Quality Assurance activities during partner audits and/or regulatory inspections, as assigned
- Participate in inspection readiness and pre-approval inspection preparation activities and collaborate with study and functional area teams, applicable partners and CROs as assigned
- Support strategic organizational quality and compliance process improvement initiatives
- Support Investigator Site Audits
- Bachelor of Science/ Bachelor of Art in a relevant discipline required (Biological or Life Sciences preferred)
- 6+ years in pharmaceutical drug development in Clinical Quality Assurance and/or GCP-related discipline.
- Previous experience which provided the knowledge, skills and abilities to meet the expectations outlined in this job description. Quality Auditor / Manager certification preferred
- Excellent working knowledge and interpretation of ICH Guidelines and GCP domestic and international regulations.
- Experience leading audits of GCP/GCLP/GPvP vendors, investigator sites, and internal audits of clinical functional areas
- Experience managing inspection readiness activities and supporting FDA, EMA, and other health authority inspections.
- Must have the ability to build and maintain positive relationships with department management, peers, and other colleagues across the organization.
- Self-motivated with the ability to take initiative, ownership and manage multiple responsibilities while shifting priorities quickly under tight timelines.
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
- Excellent oral and written communication skills.
Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.
This role can be based at our Hayward, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $165,000 - $180,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.
EOE
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
#LI-Remote
#LI-JS1
The Senior Manager, Clinical Quality Assurance is responsible for working with study management teams to facilitate internal and external adherence to Quality and Regulatory Compliance by ensuring conformance to domestic and international quality regulations and GCP guidelines. The role is accountable for participating in day-to-day QA Compliance operations in conformance with Arcus Biosciences processes and procedures.
This position supports the Clinical Quality Assurance function by providing GCP compliance oversight and support to Arcus Clinical Development therapeutic areas. A key activity of the role is providing expertise and guidance regarding applicable regulatory, Good Clinical Practice, and Arcus Standard Operating Procedure requirements for the conduct of clinical studies. Responsibilities also include inspection readiness planning, management of health authority inspections and audits by external development partners, management of clinical audit programs, and oversight of consultant auditors. This role will lead audits of investigator sites, internal functional/process audits, and audits of clinical vendors (GCP, GCLP, GPvP).
Responsibilities
- Support clinical study teams as a core team member for assigned studies through attendance at study management team meetings, review of study documents, and QA consultation on GCP-related questions
- Identify and escalate serious non-compliance issues to Clinical QA and Quality group leadership, including the assessment of serious breaches
- Maintain a high level of expertise in global GCP regulations and internal policies and procedures that impact clinical study conduct
- Clinical QA point of contact for specific clinical functional areas to support study and non-study specific projects
- Support the management of study-specific deviations/events/CAPAs in the GCP/PV space
- Collaborate with CRO quality counterparts as delegated, including participation in QA-QA meetings
- Participate in internal and external GCP audits as assigned in support of the execution of the audit programs and support the management of audit lifecycle activities as assigned, such as scheduling planning, issuing agendas, audit execution, issuing reports evaluating responses, requesting clarification, issuing CAPA, and audit closing
- Maintain up to date audit execution results in Arcus electronic quality management system (Veeva Quality Vault, preferred) and report compliance trends based on internal / external regulatory observations to ensure business continuity
- Clearly present audit findings and/or other related audit information to appropriate departmental personnel, as required
- Work directly with auditees to ensure completion of corrective and preventative actions to address compliance concerns identified during audits
- Support Quality Assurance activities during partner audits and/or regulatory inspections, as assigned
- Participate in inspection readiness and pre-approval inspection preparation activities and collaborate with study and functional area teams, applicable partners and CROs as assigned
- Support strategic organizational quality and compliance process improvement initiatives
- Support Investigator Site Audits
- Bachelor of Science/ Bachelor of Art in a relevant discipline required (Biological or Life Sciences preferred)
- 6+ years in pharmaceutical drug development in Clinical Quality Assurance and/or GCP-related discipline.
- Previous experience which provided the knowledge, skills and abilities to meet the expectations outlined in this job description. Quality Auditor / Manager certification preferred
- Excellent working knowledge and interpretation of ICH Guidelines and GCP domestic and international regulations.
- Experience leading audits of GCP/GCLP/GPvP vendors, investigator sites, and internal audits of clinical functional areas
- Experience managing inspection readiness activities and supporting FDA, EMA, and other health authority inspections.
- Must have the ability to build and maintain positive relationships with department management, peers, and other colleagues across the organization.
- Self-motivated with the ability to take initiative, ownership and manage multiple responsibilities while shifting priorities quickly under tight timelines.
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
- Excellent oral and written communication skills.
Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.
This role can be based at our Hayward, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $165,000 - $180,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.
EOE
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
#LI-Remote
#LI-JS1
Associate Director Clinical Quality Assurance Jobs by Experience Level
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Find JobsAssociate Director Clinical Quality Assurance Job Market
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals10
- Healthcare & Medical Services8
- Education2
- Consulting & Professional Services2
- Food & Beverage1
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, Arrowhead Pharmaceuticals, and MES Solutions, and the most openings are in California, Georgia, and New Jersey, based on current listings on Migrate Mate as of August 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 64% of associate director clinical quality assurance openings are fully remote or hybrid as of August 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.
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