Senior Manager, Quality Assurance (GMP Operations)

Job Description

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As the Sr Manager Quality Assurance – GMP Operations at Gilead, you will provide Quality leadership and direct quality oversight of Manufacturing and Quality Control (QC) at the Foster City site.
This role ensures GMP compliance through design, startup, and operation of a new, state-of-the-art Single Use DS Biologics Manufacturing facility and QC Laboratory in Foster City, CA. The position partners closely with Manufacturing and QC teams to enable compliant, risk-based decision making and continuous improvement while maintaining patient safety and product quality.

This is a site based role at our facility in Foster City, CA.

Knowledge:

• 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.
• Demonstrates 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.
• Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is preferred.
• Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred.

Specific Job 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.
• Provide 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.
• Review and approve 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.
• Apply 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.
• Participates in continuous improvement initiatives.
• Partner 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.

Specific Education & Experience Requirements:

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

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.