Senior Manager, Quality Assurance (GMP Operations)

About the role

The Sr Manager Quality Assurance – GMP Operations at Gilead, Foster City, CA, will provide Quality leadership and direct quality oversight of Manufacturing and Quality Control (QC) operations.

Responsibilities

• Manages, prioritizes, and participates in batch record review and release activities, including review of manufacturing, environmental monitoring, and quality control data for in-process and finished products.
• Responsible for final release of manufactured products.
• Provides Quality Assurance oversight of external QC laboratories, ensuring method lifecycle activities (qualification, verification, and validation) are executed in compliance with cGMP, ICH, and internal quality standards, with appropriate review and approval of protocols, reports, and methods.
• Reviews and approves laboratory investigations (e.g., OOS/OOT/deviations) conducted by contract partners, ensuring thorough root cause analysis, robust corrective and preventive actions (CAPA), and aligned decision-making impacting product quality and disposition.
• Manages, prioritizes, and reviews quality control data for method establishment, qualification/validation, and transfer. Applies Quality Risk Management principles to oversee risk assessments in collaboration with Manufacturing, and QC operations.
• Participates in authoring, reviewing, and approving changes to standard operating procedures, specifications, forms, and other controlled documents to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Participates in and oversees design and planning of new biologics manufacturing facility and QC laboratory.
• Participates in site inspection readiness activities and internal audits.
• Partners with internal partners to ensure resolution of quality issues.
• Participates in review/approval of Deviations, CAPAs, and Change Management records as required.
• Works on problems that are moderately complex in scope where analysis of situations or data requires in-depth evaluation of various factors. Considerable judgement is required in resolving problems and making scientific routine recommendations.

Requirements

• Demonstrates in-depth knowledge of GMPs and/or GLPs.
• Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Demonstrates keen understanding of international quality systems regulations to adopt best in class systems/processes, and drive continuous improvement initiatives.
• Knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements.
• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.
• Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred.

Qualifications

• 8+ years of experience in a GMP environment related field and a BS or BA OR 6+ years of relevant experience and a MS OR 2+ years of relevant experience and a PhD.
• Experience across broad areas of Quality Assurance and/or Quality Systems.
• Experience with interacting with regulatory agencies.

Skills

• Excellent interpersonal, verbal, and written communication skills.
• Knowledge of Risk Management tools (e.g., HACCP and FMEA).

Benefits

The salary range for this position is: $157,590.00 - $203,940.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For Additional Benefits Information, Visit here.

For Jobs In The United States Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.