Senior Manager, Quality Assurance

Gilead Sciences•Foster City, CA

2d•$157,590 - $203,940•Onsite

About The Position

The Senior Manager, Quality Assurance is accountable for strategizing and delivering Quality Assurance objectives supporting Gilead’s Foster City Manufacturing New Chess Facility (NCF). The role supports facility startup, operational readiness, and steady-state manufacturing and analytical operations, ensuring alignment with manufacturing, digital, quality control, and compliance priorities. This is a site-based individual contributor position that also includes leadership, development, and mentoring of Quality personnel.

Requirements

At least 8 years of relevant GMP-environment experience with a BS or BA, or at least 6 years with an MS, or at least 2 years of relevant experience in a GMP environment.
Hands-on experience supporting biologics, GMP manufacturing, and QC operations.
Strong understanding and experience of materials management, manufacturing, and analytical methods and testing systems within a GMP environment.
Strong cross-functional collaboration and communication skills.
In-depth knowledge of GMPs and/or GLPs and QA principles, concepts, industry practices, and standards.
Excellent verbal, written, and interpersonal communication skills.
Understanding of international quality systems regulations and ability to adopt best-in-class systems and processes and drive continuous improvement.
Knowledge of Information Systems Technology and Computer System Validation (CSV), including current electronic records and signature requirements.

Nice To Haves

Knowledge of Six Sigma, DMAIC methodology, performance measures, and quality-improvement statistics.
Knowledge of risk-management tools such as HACCP and/or FMEA.
ASQ certification (Certified Quality Auditor, Certified Quality Engineer, or Certified Quality Manager) or certification from another industry-recognized professional organization.

Responsibilities

Provide Quality Assurance oversight for GMP manufacturing and QC testing operations across the product lifecycle, from master cell bank through drug product.
Set QA strategy and oversee external QC laboratories, including cGMP-compliant method qualification, verification, validation, and review and approval of protocols, reports, and methods.
Review and approve laboratory investigations conducted by contract partners, including OOS, OOT, and deviation investigations; ensure robust root cause analysis and CAPAs.
Organize and prioritize QA personnel’s daily work, provide training, and write performance reviews.
Write or implement changes to controlled documents, including SOPs, specifications, and methods.
Implement and maintain quality programs and processes that ensure product quality and compliance with current GMPs and GLPs.
Review manufacturing, environmental monitoring, and QC data for in-process and finished products.
Make final release decisions for manufactured products.
Apply Quality Risk Management principles and oversee risk assessments in collaboration with Manufacturing and QC operations.
Work with operating entities to ensure continuing inspections, statistical process control analyses, and audits; enforce requirements and meet specifications.
Participate in developing training programs related to producing quality products.
Lead or coordinate investigations and CAPA recommendations related to manufactured products, and lead compliance audits as required.
Interface with contract manufacturers to resolve complex product and process performance issues.
Work with Research and Development during new product startups and establish checkpoints for new products and processes.
Interface with regulatory agencies as required.
Participate in internal GMP audits and routine walkthroughs of Manufacturing, QC, and Warehouse areas.
Support regulatory inspections and internal audits; monitor regulatory requirements and proactively assess operational compliance risks.
Approve GMP documentation, including risk assessments, procedures, master batch records, specifications, and analytical methods; drive continuous improvement of quality processes.
Provide leadership, development, and mentoring for Quality personnel supporting GMP operations.
Partner 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 QA support to Manufacturing and QC operations as required.
Use risk-based decision-making to prioritize work and ensure product quality; maintain working knowledge of Health Canada, FDA, and global GMP expectations.
Create inclusion, develop talent, and empower teams by modeling inclusive management, coaching employees, aligning team goals with organizational objectives, and removing barriers.