QA Operations Lead: Labeling & Systems

Exelixis, Inc.; Alameda (CA); On-site; USD 176,000 - 250,500; Full time

Benefits offered by this job

401k plan with company contributions

Medical, dental and vision coverage

15 accrued vacation days in the first year

Discretionary annual bonus program

Job summary

Exelixis, Inc. seeks an Associate QA Operations Director in Alameda to lead QA support for Quality Systems, focusing on quality events and compliance. This role demands strong leadership in managing deviation, change control, and CAPA processes.

The ideal candidate will have at least 11 years of experience in the biotech or pharmaceutical industry, supported by a relevant degree. Exceptional communication skills and an ability to manage multiple priorities are essential. A competitive compensation package is included.

Qualifications

• 11 years of related experience or 9 years with an MS/MA degree.
• Experience in pharmaceutical or biotech industries preferred.
• Demonstrated knowledge of cGMPs and regulatory requirements.

Responsibilities

• Lead QA support for deviations and CAPA management.
• Provide guidance on quality systems and best practices.
• Resolve quality issues and escalate risks as needed.

Skills

Knowledge of biotechnology/pharmaceutical sector

Excellent written and verbal communication skills

Strong time-management skills

Ability to manage multiple competing priorities

Education

BS/BA in Biology, Computer Science, or related field

MS/MA in Biology, Computer Science, or related field

Job description

Exelixis, Inc. seeks an Associate QA Operations Director in Alameda to lead QA support for Quality Systems, focusing on quality events and compliance. This role demands strong leadership in managing deviation, change control, and CAPA processes.

The ideal candidate will have at least 11 years of experience in the biotech or pharmaceutical industry, supported by a relevant degree. Exceptional communication skills and an ability to manage multiple priorities are essential. A competitive compensation package is included.