Senior Specialist, Quality Assurance

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. As a Sr. QA Specialist, you will hold a key role accountable for delivering Quality Assurance objectives supporting the Foster City Manufacturing New Chess Facility (NCF).

This role will support startup, operational readiness, and steady-state manufacturing and analytical operations while ensuring alignment with manufacturing, digital, quality control, and compliance priorities.

Our position is an individual contributor, site-based role.

Key Responsibilities:

GMP Operations Quality Oversight

• 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.
• Applies Quality Risk Management principles to oversee risk assessments in collaboration with Manufacturing and QC operations.
• Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed, to ensure defined quality objectives are met.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
• Works closely with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications.
• May participate in the development of training programs regarding all aspects of producing quality products.
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
• Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes.
• May assist or lead compliance audits as required. May interface with regulatory agencies as required.

Compliance, Audits & Inspections

• Participate in internal GMP audits and routine walk-throughs of Manufacturing, QC, and Warehouse areas to support continuous improvement.
• Support during regulatory inspections and internal audits.
• 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.

Knowledge:

• Proficient in GMPs and/or GLPs.
• Proficient in application of QA principles, concepts, industry practices, and standards.

…