Associate Director, Quality Assurance- GMP Operations

Responsibilities

• Provide senior Quality leadership and direct oversight of GMP Manufacturing, Quality Control (QC), and Supply Chain activities.
• Apply Quality Risk Management principles to identify, assess, and mitigate risks impacting product quality and patient safety.
• Review and approve manufacturing and test records, deviations, investigations, change controls, and CAPA to support timely product disposition.
• Participate in internal GMP audits and serve as a key Quality contact during regulatory inspections.
• Approve GMP documentation including procedures, master batch records, specifications, and analytical methods.
• Lead, develop, and mentor Quality personnel supporting GMP operations.
• Partner cross-functionally with Manufacturing, QC, Process Development, and Supply Chain teams on site initiatives.

Requirements

• Bachelor's degree in a scientific discipline with 10+ years of GMP QA experience in a pharmaceutical or biotech environment, OR a Master's degree with 8+ years of relevant experience.
• Extensive hands-on experience supporting GMP Manufacturing and QC operations.
• Proven experience leading batch disposition, investigations, CAPA, and change management.
• Previous experience in people management and a management role within Quality.
• Strong understanding of materials management, manufacturing, and analytical testing systems within a GMP environment.
• Excellent cross-functional collaboration and communication skills.

Preferred Qualifications

• Experience supporting Health Canada, FDA, or other global regulatory inspections.
• Strong working knowledge of global GMP expectations and regulatory requirements.

About the Company

Gilead is a research-based biopharmaceutical company that has spent more than 35 years tackling serious diseases such as HIV, viral hepatitis, COVID-19, and cancer. We work relentlessly to develop therapies that improve lives and ensure global access to life-changing scientific innovations.