GMP Operations QA Manager – Commercial | Onsite

Exelixis; Alameda (CA); Vor Ort; USD 145.000 - 183.000; Vollzeit

Benefits dieser Stelle

401k plan

Group medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Flexible spending accounts

Discretionary annual bonus

Zusammenfassung

Exelixis in Alameda, CA, is seeking an Operations QA Manager - Commercial to oversee QA for GMP operations at CMOs handling Drug Substance, Drug Product, and related materials. You will review batch records, oversee QA assessments, and support vendor management and change control across commercial and clinical materials.

The role requires biotech/pharma experience, strong regulatory knowledge, and excellent document handling and communication skills.

Qualifikationen

• Experience in biotech or pharmaceutical industry required.
• Experience in CMO oversight preferred.
• Strong knowledge of US/EU GMP regulations and quality systems.

Aufgaben

• Develops and maintains QA programs to ensure GMP compliance for commercial and clinical materials.
• Performs record review and disposition for material batches including QA assessments.
• Coordinates investigations with vendors and interdepartmental teams to resolve product quality issues.
• Oversees generation, review, and approval of GMP documents.
• Supports QA to manage vendors, contract facilities and collaborators for QA issues.

Kenntnisse

QA oversight

GMP compliance

Vendor management

Root cause analysis

Document review

Regulatory knowledge

Communication skills

Ausbildung

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

Equivalent education/experience

Tools

Word

Excel

PowerPoint

Jobbeschreibung

Exelixis in Alameda, CA, is seeking an Operations QA Manager - Commercial to oversee QA for GMP operations at CMOs handling Drug Substance, Drug Product, and related materials. You will review batch records, oversee QA assessments, and support vendor management and change control across commercial and clinical materials.

The role requires biotech/pharma experience, strong regulatory knowledge, and excellent document handling and communication skills.