Senior Operations QA Clinical GLP Manager

Role Summary

The Senior Operations QA Clinical GLP Manager develops, implements, and maintains end-to-end QA processes and activities, including GLP operations. Provides Operations QA oversight of day-to-day GMP operations at CMOs that manufacture and test Exelixis development and clinical products, including batch record review, assessment, escalation, and release per supply plans, and manages product complaints. Acts as the QA Partner and primary point of contact, representing QA in strategic forums and coordinating communication between business functions and QA to deliver on core goals and pipeline deliverables.

Responsibilities

• Represent QA as the QA Partner (Primary Point of Contact) for vendors, CMOs, development collaborators for contracts, validation, change management, GMP and GLP issues.
• Develop, implement, and continuously improve QA programs, policies and procedures to ensure GMP and GLP compliance of clinical trial material and onsite labs.
• Perform record review and batch disposition for commercial and clinical trial material, including comprehensive Quality assessment and review of GLP documents and records.
• Oversee CMOs and GLP vendors: issue/deviation management, CAPAs with vendors and cross-functional teams to resolve potential product quality issues, rapidly escalate and resolve issues.
• Generate, review/approve internal and external GMP records (MBR/EBR, stability reports/protocols, specifications, deviations, change controls, testing/packaging records, development/CMC documents submitted to regulatory agencies, GLP documents and records).
• Develop, track and manage periodic management reports, including key GMP and GLP compliance and QA metrics.
• Maintain and report CMO metrics and Operations QA metrics; evaluate and generate data to support KPIs.
• Identify and rapidly mitigate risk.
• Independently determine approaches to complex compliance issues, rapidly escalate findings, provide recommendations, and verify CAPAs were implemented and documented.
• Contribute to APQR (annual product quality review) as applicable.
• Support implementation of quality systems, departmental and corporate procedures to ensure compliance with cGMPs and GLP.
• Partner with Regulatory Affairs, Clinical Pharmacology, Translational Medicine, PSC, PSC Analytical, and R&D regarding compliance issues; provide guidance to audited parties.
• Maintain knowledge of current regulation requirements and inform stakeholders of potential impact.
• Deliver per supply plans and drive results.

Qualifications

• Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of related experience; or,
• Master’s degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 7 years of related experience; or,
• PhD in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 2 years of related experience; or,
• Equivalent combination of education and experience.

Skills

• Demonstrated knowledge of the drug development processes
• Demonstrated GLP audit conduct and management experience
• Working knowledge of GLP preparation and submission activities for global regulatory filings
• Working knowledge of end-to-end commercial and clinical manufacturing and quality processes, US/EU regulations, and ICH guidelines
• Experience in virtual manufacturing environments or relevant industry
• Broad knowledge of biologic and chemical processes, drug development, analytical testing methods, laboratory practices, and regulatory landscape
• Knowledge of small molecule, oral solid form, and biologics
• Ability to drive objectives with creative and effective solutions
• Ability to implement technical solutions within quality requirements to complex problems
• Interprets and modifies company-wide policies and programs as needed
• Strong attention to detail
• Strong analytical and business communication skills; ability to evaluate and generate data for departmental metrics
• Excellent written, verbal, and presentation communication; ability to translate complex concepts across all levels
• Proficient in MS Office (Word, Excel, PowerPoint)

Education

• Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or related)
• Master’s degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or related)
• PhD in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or related)
• Equivalent combination of education and experience

Additional Requirements

• This is an onsite position
• Up to 5% travel
• Work environment emphasizes collaboration and requires standard office equipment and setup