Senior Level Associate Director Clinical Quality Assurance Jobs
Senior level associate director clinical quality assurance jobs place experienced professionals in charge of GCP compliance strategy, audit programs, and the clinical operations teams that execute them. Roles are concentrated across Biotechnology & Pharmaceuticals, Consulting & Professional Services, and Medical Devices, with a mix of on-site, hybrid, and remote openings, and employers like Abbott, Celerion, and Beam Therapeutics hiring at this level now.
Find JobsOverview
Showing 5 of 168+ Senior Level Associate Director Clinical Quality Assurance jobs
The Position
This role is a valuable part of our Hillsboro Innovative Therapies (HIT) Quality Systems and Validation team, which is committed to achieving our mission of delivering novel and exciting biopharmaceutical technologies to patients. As a member of this dedicated cross-functional team, you will drive production start-up activities and establish the foundational quality approach for new facilities. You will have the opportunity to collaborate closely with key stakeholders in Engineering, Operations, and global network teams to ensure our systems and processes are safe, compliant, and inspection-ready.
The Opportunity
As a Senior Quality Assurance Engineer, you will provide day-to-day Quality Oversight for site qualification, equipment validation, and computer system validation during critical production start-up activities. You will act as the site Quality and Regulatory Subject Matter Expert (SME), ensuring that all local processes and automated systems strictly align with current Good Manufacturing Practices (cGMPs). Key responsibilities include:
- Lead Quality Oversight: Provide technical and regulatory oversight for site qualification and validation activities, including advanced Computer System Validation (CSV).
- Approve Critical Validation: Review and approve essential lifecycle documentation such as Validation Master Plans, User Requirements, Protocols, deviations, and Summary Reports.
- Support Engineering & Design: Collaborate during the build and deploy phases to support user requirement definitions and design specifications for production and laboratory equipment.
- Defend Inspection Readiness: Maintain the compliance status of assigned areas to ensure a constant state of inspection readiness, and directly present and defend the validation program during regulatory audits.
- Manage Risk & Changes: Provide technical quality assessments and approvals for engineering modifications, process changes, and Corrective and Preventive Actions (CAPAs) while managing the validation risk log.
- Drive Continuous Improvement: Partner with interdepartmental, multi-site, and global corporate teams to implement validation best practices and benchmark against industry standards.
Who You Are
- Education & Experience: Bachelor’s degree (preferably in Engineering or Life Sciences) with a minimum of 8 years of pharmaceutical/biopharmaceutical industry experience, or a Master’s degree with a minimum of 6 years of relevant industry experience. Cell therapy experience is preferred.
- Validation & Engineering Expertise: Possess sound knowledge of engineering principles, qualification concepts, and regulatory requirements as they relate to system performance and laboratory design/start-up activities.
- Automation & Systems Knowledge: Technical familiarity with the design, build, and deployment of automation and execution systems (such as Delta V/SCADA, Syncade MES, BAS, EBR, and Pi Data historian) within a regulated environment.
- Regulatory & Risk Frameworks: Strong understanding of US and EU cGMPs, validation guidelines, and Risk Assessment Methodologies (such as PHA, FMEA, and FTA).
- Decision-Making & Quality Analysis: Demonstrated ability to interpret complex Quality standards, make sound technical decisions, and troubleshoot cross-functional quality issues effectively.
- Collaborative Communication: Excellent verbal and written communication skills with a proven track record of working collaboratively in cross-functional teams to achieve project milestones.
- Physical & Travel Requirements: Ability to meet standard office physical demands (sitting/standing for extended periods, lifting up to 25 lbs) and a willingness to travel up to 30% to other sites as required.
The expected salary range for this position based on the primary location of Oregon is $93,000 - $172,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed in this link.
This is an on-site position.
Relocation benefits are not approved for this posting.
LI-CA1
ptcareers
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
JOB FACTS
- Job Sub Category: Quality
- Schedule: Full time
- Job Type: Regular
- Posted Date: Jul 9th 2026
- Job ID: 202607-117905
The Position
This role is a valuable part of our Hillsboro Innovative Therapies (HIT) Quality Systems and Validation team, which is committed to achieving our mission of delivering novel and exciting biopharmaceutical technologies to patients. As a member of this dedicated cross-functional team, you will drive production start-up activities and establish the foundational quality approach for new facilities. You will have the opportunity to collaborate closely with key stakeholders in Engineering, Operations, and global network teams to ensure our systems and processes are safe, compliant, and inspection-ready.
The Opportunity
As a Senior Quality Assurance Engineer, you will provide day-to-day Quality Oversight for site qualification, equipment validation, and computer system validation during critical production start-up activities. You will act as the site Quality and Regulatory Subject Matter Expert (SME), ensuring that all local processes and automated systems strictly align with current Good Manufacturing Practices (cGMPs). Key responsibilities include:
- Lead Quality Oversight: Provide technical and regulatory oversight for site qualification and validation activities, including advanced Computer System Validation (CSV).
- Approve Critical Validation: Review and approve essential lifecycle documentation such as Validation Master Plans, User Requirements, Protocols, deviations, and Summary Reports.
- Support Engineering & Design: Collaborate during the build and deploy phases to support user requirement definitions and design specifications for production and laboratory equipment.
- Defend Inspection Readiness: Maintain the compliance status of assigned areas to ensure a constant state of inspection readiness, and directly present and defend the validation program during regulatory audits.
- Manage Risk & Changes: Provide technical quality assessments and approvals for engineering modifications, process changes, and Corrective and Preventive Actions (CAPAs) while managing the validation risk log.
- Drive Continuous Improvement: Partner with interdepartmental, multi-site, and global corporate teams to implement validation best practices and benchmark against industry standards.
Who You Are
- Education & Experience: Bachelor’s degree (preferably in Engineering or Life Sciences) with a minimum of 8 years of pharmaceutical/biopharmaceutical industry experience, or a Master’s degree with a minimum of 6 years of relevant industry experience. Cell therapy experience is preferred.
- Validation & Engineering Expertise: Possess sound knowledge of engineering principles, qualification concepts, and regulatory requirements as they relate to system performance and laboratory design/start-up activities.
- Automation & Systems Knowledge: Technical familiarity with the design, build, and deployment of automation and execution systems (such as Delta V/SCADA, Syncade MES, BAS, EBR, and Pi Data historian) within a regulated environment.
- Regulatory & Risk Frameworks: Strong understanding of US and EU cGMPs, validation guidelines, and Risk Assessment Methodologies (such as PHA, FMEA, and FTA).
- Decision-Making & Quality Analysis: Demonstrated ability to interpret complex Quality standards, make sound technical decisions, and troubleshoot cross-functional quality issues effectively.
- Collaborative Communication: Excellent verbal and written communication skills with a proven track record of working collaboratively in cross-functional teams to achieve project milestones.
- Physical & Travel Requirements: Ability to meet standard office physical demands (sitting/standing for extended periods, lifting up to 25 lbs) and a willingness to travel up to 30% to other sites as required.
The expected salary range for this position based on the primary location of Oregon is $93,000 - $172,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed in this link.
This is an on-site position.
Relocation benefits are not approved for this posting.
LI-CA1
ptcareers
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
JOB FACTS
- Job Sub Category: Quality
- Schedule: Full time
- Job Type: Regular
- Posted Date: Jul 9th 2026
- Job ID: 202607-117905
See All 168+ Senior Level Associate Director Clinical Quality Assurance Jobs
Find roles that match your experience and apply in just a few clicks.
Find JobsSenior Level Associate Director Clinical Quality Assurance Job Market
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals37
- Consulting & Professional Services13
- Medical Devices12
- Electronics & Hardware12
- Technology & Software10
Senior Level Associate Director Clinical Quality Assurance Jobs: Frequently Asked Questions
How do I get a senior level associate director clinical quality assurance job?
Employers at this level look for candidates who have owned end-to-end quality systems, led inspection readiness programs, and managed cross-functional teams through regulatory submissions or audits. Demonstrated experience driving CAPA resolution, authoring SOPs, and influencing stakeholders outside QA gives candidates a clear edge. A history of building or restructuring QA functions signals the leadership maturity these roles require.
Which companies hire senior level associate director clinical quality assurances?
Companies hiring senior level associate director clinical quality assurances right now include Abbott, Celerion, and Beam Therapeutics, based on current listings on Migrate Mate as of July 2026. Hiring at this level comes primarily from mid-size to large pharmaceutical, biotechnology, and contract research organizations that operate regulated clinical development programs and require seasoned QA leadership.
Are there remote senior level associate director clinical quality assurance jobs?
Yes, though availability varies by organization and therapeutic focus. About 24% of senior level associate director clinical quality assurance openings are remote or hybrid as of July 2026, reflecting broader flexibility in QA leadership roles that center on oversight and strategy rather than hands-on site work. Fully on-site positions remain common at larger sponsor companies and CROs with established quality operations.
What makes an associate director clinical quality assurance role senior level?
Senior level roles carry program-wide or functional ownership rather than task execution. Expectations include setting quality strategy across multiple studies or therapeutic areas, leading audits independently, mentoring junior QA staff, and representing quality in cross-functional governance forums. The distinction from mid-level roles is accountability for outcomes, not just activities, and the ability to influence regulatory and operational decisions without close supervision.
Which industries hire the most senior level associate director clinical quality assurances?
Senior level associate director clinical quality assurance roles concentrate in Biotechnology & Pharmaceuticals, Consulting & Professional Services, and Medical Devices, based on current listings on Migrate Mate as of July 2026. These sectors drive hiring because they operate active clinical pipelines under FDA and ICH GCP oversight, requiring experienced QA leaders who can scale compliance infrastructure alongside rapidly evolving trial portfolios.