Associate Director, 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. 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 and improvement initiatives.
• Provide on-call Quality Assurance support to Manufacturing and QC operations, as required.
• Use risk-based decision making to prioritize tasks and ensure product quality.
• Maintain strong working knowledge of Health Canada, FDA, and global GMP expectations.

Specific Education & Experience Requirements:

• 10+ years of relevant experience in a GMP environment related field and a Bachelor’s degree in science or related field **OR**
• 8+ years of relevant experience and a MS **OR**
• 5+ years of relevant experience and a PharmD/ PhD
• Extensive hands-on experience supporting biologics, GMP Manufacturing and QC operations is required.
• Proven experience leading investigations, CAPA, and change management in a GMP operational environment is required.
• Strong understanding and experience of materials management, manufacturing and analytical methods and testing systems within a GMP environment.
• Previous experience in people management within Quality is required.
• Strong cross-functional collaboration and communication skills are required.

Preferred:

• Experience supporting Health Canada, FDA, or other regulatory inspections

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.