Manager, Supplier and Vendor Audit Program
Lyell Immunopharma
4 hours ago
Remote friendly (Bothell, WA)
United States
Operations
Responsibilities:
- Design, execute, and oversee the supplier and vendor oversight program and the internal audit program
- Assess GxP suppliers; execute supplier questionnaires and audits as required
- Create and maintain the audit schedule and the Approved Supplier List
- Lead cross-functional teams to evaluate suppliers and vendors based on quality and criticality
- Document, track, distribute, and follow up on actions from supplier questionnaires in the Quality Management System
- Plan, execute, and report on virtual and on-site supplier/vendor audits
- Plan, execute, and report on internal audits
- Support third-party audits hosted onsite
- Own and facilitate the Material Review Board
- Participate in cross-functional teams bringing in new materials and vendors
Preferred Education:
- BA/BSc with 10+ years’ experience; or MBA/MSc with 7+ years’ experience
- Professional Auditor Certification
Preferred Experience:
- 12+ years in GMP biopharmaceutical operations, including 8+ years in GMP Quality, and 5+ years as an auditor
- Demonstrated experience in Clinical and GMP manufacturing
- Proven experience with quality management systems (e.g., Deviations, CAPA, Risk)
Knowledge/Skills/Abilities:
- Deep knowledge of GMP regulations for cell therapy companies (US, Canada, Australia, Europe, Japan)
- Ability to work non-traditional hours for remote audits
- Travel up to 10% for on-site audits
- Strong leadership, collaboration, influencing, problem-solving, and change-driving skills
- Motivated, organized critical thinker with strong interpersonal and business communication skills
- Ability to work in a fast-paced start-up environment
Benefits:
- Salary range: $124,000–150,000 annually; opportunity for annual bonus and eligibility for Equity Incentive Plan
- Subsidized medical, dental, and vision; FSA; life and AD&D, STD, LTD; ESPP; 401(k) match; mass transit commuter benefits; cell phone reimbursement; supplemental benefits
- Flexible time off; 8 observed holidays; floating holiday; winter office shutdown
- Design, execute, and oversee the supplier and vendor oversight program and the internal audit program
- Assess GxP suppliers; execute supplier questionnaires and audits as required
- Create and maintain the audit schedule and the Approved Supplier List
- Lead cross-functional teams to evaluate suppliers and vendors based on quality and criticality
- Document, track, distribute, and follow up on actions from supplier questionnaires in the Quality Management System
- Plan, execute, and report on virtual and on-site supplier/vendor audits
- Plan, execute, and report on internal audits
- Support third-party audits hosted onsite
- Own and facilitate the Material Review Board
- Participate in cross-functional teams bringing in new materials and vendors
Preferred Education:
- BA/BSc with 10+ years’ experience; or MBA/MSc with 7+ years’ experience
- Professional Auditor Certification
Preferred Experience:
- 12+ years in GMP biopharmaceutical operations, including 8+ years in GMP Quality, and 5+ years as an auditor
- Demonstrated experience in Clinical and GMP manufacturing
- Proven experience with quality management systems (e.g., Deviations, CAPA, Risk)
Knowledge/Skills/Abilities:
- Deep knowledge of GMP regulations for cell therapy companies (US, Canada, Australia, Europe, Japan)
- Ability to work non-traditional hours for remote audits
- Travel up to 10% for on-site audits
- Strong leadership, collaboration, influencing, problem-solving, and change-driving skills
- Motivated, organized critical thinker with strong interpersonal and business communication skills
- Ability to work in a fast-paced start-up environment
Benefits:
- Salary range: $124,000–150,000 annually; opportunity for annual bonus and eligibility for Equity Incentive Plan
- Subsidized medical, dental, and vision; FSA; life and AD&D, STD, LTD; ESPP; 401(k) match; mass transit commuter benefits; cell phone reimbursement; supplemental benefits
- Flexible time off; 8 observed holidays; floating holiday; winter office shutdown