Senior Operations QA Manager - Labeling & Systems (QA Core)

$140,000 - $199,000/Yr

Exelixis - Alameda, CA

Full-time - Senior

Alameda, CA

Professional, Scientific, and Technical Services

About the position

The Senior Operations QA Manager - Labeling and Quality Systems is responsible for overseeing Quality Management Systems and ensuring compliance with health authority regulations in GMP Operations. This role involves applying Quality tools to drive continuous improvement, managing labeling and distribution activities, and collaborating with various stakeholders to align strategic objectives. The successful candidate will implement harmonization processes and support the transition from clinical to commercial products, while maintaining a high level of independent quality judgment.

Responsibilities

• Support QA Partners and maintain/improve Quality systems and projects using lean six sigma tools.
• Execute labeling, systems, and distribution activities as applicable.
• Drive change and results through key projects to close gaps and support business advancement.
• Generate and maintain sustainable, robust, and lean Quality Systems.
• Ensure compliance with health authority regulations and guidelines.
• Track and trend systems, providing metrics for audits and inspections.
• Rapidly resolve quality issues, identify and mitigate risks, and propose feasible solutions.
• Lead process and system improvements and interpret Health Authority regulations across Quality Systems.
• Review new regulations to ensure compliance and support product transitions from clinical to commercial.

Requirements

• BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline with a minimum of nine years of related experience; or MS/MA degree with a minimum of seven years of related experience.
• Ideally, a minimum of 10 years of QA experience in biotech, pharmaceutical, or related industry.
• Demonstrated knowledge of GxP, Health Authority Regulations, Quality Systems, and technical expertise in warehousing/storage and transportation/shipping processes.
• Knowledge of biologics and chemical products preferred; international/global experience preferred.
• Experience with regulatory inspections and audits, presenting or defending departmental systems.

Nice-to-haves

• Knowledge of FDA, EU/ROW regulatory requirements related to storage and shipping validation expectations.

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