GMP QA Operations Manager: Vendor Oversight

Regulatory Jobs; Alameda (CA); Sur place; USD 145 000 - 183 000; Plein temps

Avantages offerts par ce poste

401k plan

Comprehensive medical/dental/vision

Discretionary annual bonus

Stock purchase program

Résumé du poste

Exelixis is seeking an Operations QA Manager - Commercial to lead QA oversight of GMP operations across CMOs handling Drug Substance, Drug Product, Intermediates, Raw Materials, Packaging and Labeling in Alameda, CA.

You will assess vendor processes, review batch records, and escalate risks to products while ensuring compliance with US/EU regulatory requirements. Strong leadership, documentation and communication skills are essential for this role.

Qualifications

• BS/BA in related discipline with a minimum of 7 years of related experience; or, MS/MA with 5 years; or PhD with 0 or more years; or equivalent.
• Experience in biotech or pharmaceutical industry is required; CMO oversight preferred.

Responsabilités

• Develop QA programs to ensure GMP compliance of commercial and clinical materials.
• Perform record review and disposition for commercial and clinical materials including QA assessments.
• Coordinate investigations with vendors and interdepartmental teams for quality issues.
• Oversee generation, review, and approval of GMP documents.
• Support QA partners to manage vendors, contract facilities, and joint development collaborators.
• Support implementation of quality systems and regulatory guidance.

Connaissances

QA oversight

Regulatory knowledge

Analytical skills

Business communication

Microsoft Office

Documentation review

Vendor management

GMP compliance

Project leadership

Biotech knowledge

Formation

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

Equivalent combination of education and experience

Outils

Word

Excel

PowerPoint

Description du poste

Exelixis is seeking an Operations QA Manager - Commercial to lead QA oversight of GMP operations across CMOs handling Drug Substance, Drug Product, Intermediates, Raw Materials, Packaging and Labeling in Alameda, CA.

You will assess vendor processes, review batch records, and escalate risks to products while ensuring compliance with US/EU regulatory requirements. Strong leadership, documentation and communication skills are essential for this role.