Senior Manager, Quality Assurance

Gilead Sciences • Foster City, CA

13h • $157,590 - $203,940 • Onsite

About The Position

The Senior Manager, Quality Assurance is accountable for strategizing and delivering Quality Assurance objectives supporting Gilead’s Foster City Manufacturing New Chess Facility (NCF). This site-based individual contributor role supports startup, operational readiness, and steady-state manufacturing and analytical operations while aligning with manufacturing, digital, quality control, and compliance priorities.

The role provides QA oversight across GMP manufacturing and QC testing operations throughout the product lifecycle, from master cell bank to drug product. Responsibilities include oversight of external QC laboratories and their method lifecycle activities; review of laboratory investigations and CAPAs; review of manufacturing, environmental monitoring, and QC data; and final release of manufactured products. The role also supports quality systems, controlled documentation, risk management, audits, inspections, operational projects, and cross-functional collaboration.

The position provides leadership, development, and mentoring for Quality personnel supporting GMP operations, while partnering with Manufacturing, QC, Process Development, Engineering, Supply Chain, and Quality management. It provides on-call QA support to Manufacturing and QC operations as required.

The stated salary range is $157,590.00–$203,940.00. The position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package including company-sponsored medical, dental, vision, and life insurance plans.

Requirements

• At least 8 years of experience in a GMP-related field with a BS or BA; or at least 6 years of relevant GMP-related experience with an MS; or at least 2 years of relevant GMP-related experience.
• Hands-on experience supporting biologics, GMP manufacturing, and QC operations.
• Strong understanding and experience of materials management, manufacturing, and analytical methods and testing systems in a GMP environment.
• Strong cross-functional collaboration and communication skills.
• In-depth knowledge of GMPs and/or GLPs.
• In-depth knowledge of QA principles, concepts, industry practices, and standards.
• Excellent verbal, written, and interpersonal communication skills.
• Understanding of international quality systems regulations and ability to adopt best-in-class systems and processes and drive continuous improvement.
• Knowledge of information systems technology and Computer System Validation (CSV), including current electronic records and signature requirements.

Nice To Haves

• Knowledge of Six Sigma, DMAIC methodology, performance measures, and quality-improvement statistics.
• Knowledge of risk management tools such as HACCP and/or FMEA.
• ASQ certification (Certified Quality Auditor, Certified Quality Engineer, or Certified Quality Manager) or certification from another industry-recognized professional organization.

Responsibilities

• Develop and deliver Quality Assurance objectives for the Foster City Manufacturing New Chess Facility.
• Support facility startup, operational readiness, and ongoing manufacturing and analytical operations.
• Provide QA strategy and oversight for external QC laboratories, including qualification, verification, and validation of methods, and review and approval of related protocols, reports, and methods.
• Review and approve contract partner laboratory investigations, including OOS, OOT, and deviation investigations; ensure robust root cause analysis, corrective and preventive actions, and aligned product-quality and disposition decisions.
• Organize and prioritize QA personnel’s daily tasks, provide training, and write performance reviews.
• Write or implement changes to controlled documents, including SOPs, specifications, and methods.
• Implement and maintain programs and processes that support product quality and compliance with GMPs and GLPs.
• Review manufacturing, environmental monitoring, and QC data for in-process and finished products.
• Perform final release of manufactured products.
• Apply Quality Risk Management principles and oversee risk assessments with Manufacturing and QC operations.
• Work with operating entities to support continuing inspections, statistical process control analyses, and audits.
• Participate in or develop training programs related to producing quality products.
• Lead or coordinate investigations and recommend CAPAs related to manufactured products.
• Lead compliance audits as required and interface with contract manufacturers to resolve complex product or process performance issues.
• Work with Research and Development on new product startups and establish checkpoints for new products and processes.
• Interface with regulatory agencies as required.
• Participate in internal GMP audits and routine walkthroughs of Manufacturing, QC, and Warehouse areas.
• Support regulatory inspections and internal audits, monitor regulatory requirements, and assess potential operational compliance risks.
• Approve GMP documentation, including risk assessments, procedures, master batch records, specifications, and analytical methods.
• Drive continuous improvement of quality processes supporting GMP operations.
• Provide leadership, development, and mentoring for Quality personnel.
• Partner with Manufacturing, QC, Process Development, Engineering, Supply Chain, and Quality management on site and corporate initiatives.
• Lead or support quality-related operational projects and improvement initiatives.
• Provide on-call QA support to Manufacturing and QC operations as required.
• Use risk-based decision making to prioritize work and ensure product quality.
• Maintain working knowledge of Health Canada, FDA, and global GMP expectations.
• Create an inclusive environment, develop talent through coaching and feedback, and empower teams by aligning goals and removing barriers.

Benefits

• May be eligible for a discretionary annual bonus.
• May be eligible for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.
• Benefits package, subject to applicable plan terms and conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior