Senior GMP QA Manager - Commercial Operations

Exelixis, Inc.; Alameda (CA); On-site; USD 145,000 - 183,000; Full time

Benefits offered by this job

401k plan with generous company"s"

Group medical

Dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock purchase program

Long-term incentives

Paid vacation days

Job summary

Exelixis, Inc. in Alameda, CA is seeking an Operations QA Manager - Commercial to provide QA oversight of day-to-day GMP operations at CMOs involved in Drug Substance, Drug Product, Intermediates, Raw Materials, Packaging and Labeling.

You will review batch records, lead QA assessments, and coordinate investigations with vendors and interdepartmental teams to resolve potential product quality issues, while ensuring compliance with US/EU regulations.

Qualifications

• BS/BA in related discipline with 7+ years of experience; MS/MA with 5+ years; PhD with 0+ years; or equivalent combination of education and experience.
• Experience in biotech/pharmaceutical industry required; CMO oversight preferred.
• Knowledge of US and EU regulations affecting pharma.
• Strong analytical and communication skills; proficiency in Word, Excel, PowerPoint.

Responsibilities

• Develops and maintains QA programs, policies, and procedures for GMP compliance of commercial and clinical material.
• Reviews batch records and conducts 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 collaboration contracts.

Skills

QA management

Regulatory compliance

Vendor oversight

Analytical skills

Communication

Education

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

Equivalent education/experience

Tools

Microsoft Office

GMP documentation systems

Job description

Exelixis, Inc. in Alameda, CA is seeking an Operations QA Manager - Commercial to provide QA oversight of day-to-day GMP operations at CMOs involved in Drug Substance, Drug Product, Intermediates, Raw Materials, Packaging and Labeling.

You will review batch records, lead QA assessments, and coordinate investigations with vendors and interdepartmental teams to resolve potential product quality issues, while ensuring compliance with US/EU regulations.