Associate Director, Quality Assurance (GMP Operations)

About this role

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.   Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.   We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

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. The Associate Director, Quality Assurance – GMP Operations provides senior 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 Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

• Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.

• Demonstrates keen understanding of Computer Systems Validation and ICH Guidelines.

• Demonstrates excellent verbal, written and interpersonal communication skills.

• Demonstrates knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical.

• Demonstrates working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)).

• Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations.

Key Responsibilities: GMP Operations Quality Oversight • Provide Quality Assurance oversight of GMP Manufacturing and QC testing operations through the product lifecycle from master cell bank to drug product. .

• Provide Quality Assurance strategy and 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.

• Apply Quality Risk Management principles to oversee risk assessments in collaboration with Manufacturing, and QC operations.

• Partner with cross-functional teams to identify, assess, and mitigate quality risks impacting product quality, patient safety, and supply continuity.

• Ensure quality risk decisions are appropriately justified, documented, and aligned with internal procedures and regulatory expectations.

• Partner with Manufacturing operations and QC to resolve quality issues arising during manufacturing, laboratory activities and material receipt and shipping.Oversee implementation and manufacturing workflow development for the startup of digital manufacturing and data solutions in collaboration with manufacturing, automation, engineering, and information technology teams.

• Review and approve manufacturing and test records, deviations, investigations, change controls, and CAPA to ensure product quality and support timely product disposition.

• Evaluate operational and quality risks related to new product introduction.

Compliance, Audits & Inspections • Participate in internal GMP audits and routine walk-throughs of Manufacturing, QC, and Warehouse areas to support continuous improvement.

• Serve as a key Quality contact during regulatory inspections and internal audits, including preparation and response to findings.

• Monitor regulatory requirements and proactively assess potential operational compliance risks.

Quality Systems & Documentation • Approve GMP documentation including risk assessments, procedures, master batch records, specifications, and analytical methods.Drive continuous improvement of quality processes supporting GMP operations.

Leadership & Collaboration • Provide leadership, development, and mentoring for Quality personnel supporting GMP operations.

• Partner cross-functionally with Manufacturing, QC, Process Development, Engineering, Supply Chain, and Quality management on corporate and site initiatives.

• Lead or support Quality-related operational projects

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