GMP Quality Assurance Operations Manager

Exelixis Inc; Alameda (CA); Sur place; USD 145 000 - 183 000; Plein temps

Avantages offerts par ce poste

401k plan with generous company

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Sales-based incentive plan

Opportunity to purchase company stock

Long-term incentives

Vacation and holidays

Résumé du poste

Exelixis Inc. seeks an Operations QA Manager - Commercial to oversee end-to-end GMP operations at CMOs, including drug substance, product, renders, raw materials, packaging and labeling.

You will assess vendor processes and review batch records, partnering to mitigate risks to products from vendor sites and collaborators. The role requires strong GMP knowledge, regulatory understanding and the ability to drive quality programs across multiple facilities.

Qualifications

• BS/BA or MS/MA or PhD in a related field plus 5–7 years of experience, or equivalent.
• Experience in biotech/pharma and CMO oversight is preferred.
• Working knowledge of commercial and clinical manufacturing quality processes.
• Familiarity with US/EU regulatory guidance for pharmaceuticals.

Responsabilités

• Develops and maintains QA programs to ensure GMP compliance for commercial and clinical materials.
• Performs record reviews and disposition activities for material including QA assessments.
• Coordinates investigations with vendors and cross-functional teams to resolve quality issues.
• Oversees generation, review and approval of GMP documents and batch records.
• Supports vendor management for contracts, validation, changes, and QA issues.
• Implements quality systems and updates procedures to ensure GMP compliance.
• Monitors regulatory policies and advises on QA events to leadership.
• Authors work instructions and standard operating procedures; drives for results.

Connaissances

GMP knowledge

Vendor oversight

Quality systems

Regulatory understanding

Analytical skills

Excellent communication

Formation

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

Outils

Microsoft Word

Microsoft Excel

PowerPoint

Description du poste

Exelixis Inc. seeks an Operations QA Manager - Commercial to oversee end-to-end GMP operations at CMOs, including drug substance, product, renders, raw materials, packaging and labeling.

You will assess vendor processes and review batch records, partnering to mitigate risks to products from vendor sites and collaborators. The role requires strong GMP knowledge, regulatory understanding and the ability to drive quality programs across multiple facilities.