Senior Operations QA Manager Clinical (Core)

$140,000 - $199,000/Yr

Exelixis - Alameda, CA

Full-time - Senior

Alameda, CA

Professional, Scientific, and Technical Services

About the position

The Senior Manager, Operations QA - Clinical is responsible for overseeing the quality assurance (QA) of GMP operations at Contract Manufacturing Organizations (CMOs) for Exelixis' development and clinical products. This role involves ensuring compliance with regulatory standards, managing product complaints, and maintaining strong partnerships with CMOs. The position requires a high level of independent judgment and expertise in biologic and chemical processes, drug development, and analytical testing methods.

Responsibilities

• Support QA Partner and maintain QA programs, policies, and procedures for GMP compliance.
• Perform record review and batch disposition for clinical trial materials.
• Oversee CMOs regarding deviations, CAPAs, and issue resolution.
• Generate and review GMP records including MBR, EBR, stability reports, and change controls.
• Maintain and report CMO and QA metrics.
• Identify and mitigate risks rapidly.
• Contribute to the annual product quality review (APQR) as applicable.
• Support the implementation of quality systems and compliance with cGMPs.
• Evaluate and generate data to support Key Performance Indicators (KPIs).
• Ensure delivery per supply plans and drive results.

Requirements

• Bachelor's degree in science (biology, chemistry, pharmacy, medical, mathematics, engineering, or related field) with a minimum of 9 years of related experience; or a Master's degree with a minimum of 7 years; or a PhD with a minimum of 2 years; or equivalent combination of education and experience.
• A minimum of 8 years of related QA experience or equivalent combination of experience and education/training.
• Experience in the biotech or pharmaceutical industry, particularly in clinical packaging/labeling activities is preferred.
• Two years of experience managing Contract Manufacturing Organizations preferred.
• Five years of general experience in the biotech/pharmaceutical industry.
• Experience in developing metrics and continuous improvements is preferred.

Nice-to-haves

• Experience in a virtual manufacturing environment or relevant industry/profession.
• Small molecule, oral solid form, biologics technical knowledge.

Benefits

• 401k plan with generous company contributions
• Group medical, dental, and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program
• Opportunity to purchase company stock
• Long-term incentives
• 15 accrued vacation days in the first year
• 17 paid holidays including a company-wide winter shutdown
• Up to 10 sick days throughout the calendar year