Senior Operations QA Clinical GLP Manager
Location: Onsite | Full-Time
Department: Quality Assurance – Clinical & GLP
Position Summary
The Senior Operations QA Clinical GLP Manager is responsible for developing, implementing, and maintaining end-to-end Quality Assurance processes across GLP and GMP operations. This role provides QA oversight for Drug Substance, Drug Product, and Finished Goods manufactured at Contract Manufacturing Organizations (CMOs) supporting Exelixis’ clinical and development pipeline. Responsibilities include batch record review, issue escalation, product release, compliance monitoring, and management of product complaints.
Serving as the QA Partner and primary point of contact, this position represents Quality Assurance in strategic forums, communicates with internal and external stakeholders, and ensures alignment with company objectives and regulatory requirements. The role requires strong independent judgment, extensive knowledge of GLP/GMP regulations, and expertise in biologic and chemical processes.
Key Responsibilities
Act as the QA Partner and primary QA representative for vendors, CMOs, and development collaborators.
Develop, implement, and continuously improve QA programs, policies, and procedures to maintain GLP and GMP compliance across clinical trial materials and laboratory operations.
Perform detailed record review, quality assessments, and batch disposition for commercial and clinical materials.
Oversee CMOs and GLP vendors, including deviation handling, CAPA management, and rapid issue escalation.
Review and approve internal and external GMP/GLP documentation such as MBRs, EBRs, stability protocols, specifications, testing records, labeling/packaging documentation, and regulatory submissions.
Prepare and manage periodic management reports, QA metrics, and CMO performance dashboards.
Evaluate data for KPI development and contribute to continuous improvement activities.
Identify and mitigate compliance risks, recommend resolutions, and verify implementation of corrective actions.
Support APQR activities and aid in the implementation of quality systems and corporate procedures.
Collaborate with Regulatory Affairs, Clinical Pharmacology, Translational Medicine, PSC, CMC, Analytical teams, and R&D on GLP/GMP compliance needs.
Maintain and interpret current global regulatory requirements and communicate impacts to stakeholders.
Ensure timely release aligned with supply plans and operational objectives.
Supervisory Responsibilities
This role does not include direct supervisory duties.
Education Requirements
Bachelor’s degree in biology, chemistry, pharmacy, medical sciences, mathematics, engineering, or related field with 9+ years of related experience, or
Master’s degree in a relevant field with 7+ years of related experience, or
PhD in a relevant discipline with 2+ years of related experience, or
Equivalent combination of education and experience.
Experience Required
Minimum 8 years of Quality Assurance experience within the biotechnology or pharmaceutical industry.
Minimum 5 years of general industry experience in biotech/pharma.
Experience in clinical packaging and labeling activities preferred.
At least 2 years of experience managing CMOs strongly preferred.
Experience with GLP audit management, GLP documentation, and regulatory submissions.
Experience developing metrics, performance dashboards, and continuous improvement processes.
Knowledge, Skills, and Competencies
Strong understanding of drug development, GLP/GMP compliance, analytical testing, lab practices, and toxicology studies.
Expertise in small molecules, oral solid dosage forms, and biologics.
In-depth knowledge of US/EU regulatory frameworks and ICH guidelines.
Proven ability to operate in a virtual manufacturing environment.
Ability to interpret and execute complex regulatory and quality requirements.
Excellent analytical thinking, problem-solving, and business communication skills.
Ability to translate complex technical information for diverse internal stakeholders.
High attention to detail with strong organizational and documentation skills.
Proficiency in Microsoft Word, Excel, PowerPoint, and related QA documentation systems.
Work Environment
This position is fully onsite.
Modern, collaborative office environment with ergonomic equipment and open space design.
Up to 5% travel may be required.
Compensation
The base salary range for this role is USD 165,000 – USD 235,000 annually, based on geographic market, experience, skills, and internal equity.
Total Rewards Package Includes
401(k) with company contributions
Medical, dental, and vision insurance
Life and disability coverage
Flexible spending accounts
Eligibility for annual bonus or sales-based incentive programs
Employee stock purchase and long-term incentive programs
15 vacation days in the first year
17 paid holidays, including winter shutdown
Up to 10 annual sick days
Disclaimer
This job description outlines the primary duties and responsibilities of the position. It is not intended to be an exhaustive list of all tasks, qualifications, or responsibilities required.
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