Associate QA Ops Director, Labeling & Systems

Exelixis Inc; Alameda (CA); On-site; USD 130,000 - 160,000; Full time

Job summary

Exelixis Inc in Alameda, California, is seeking an Associate QA Operations Director to provide quality assurance leadership for labeling and systems. The role requires extensive experience in the pharmaceutical industry, ensuring compliance with quality standards and managing complex quality events.

Key responsibilities include overseeing deviation management and ensuring the effectiveness of quality systems. The ideal candidate will possess a strong educational background in Biology or related fields and have a proven track record in risk management and regulatory compliance.

Qualifications

• 11 years of related experience in QA operations or 9 years with a Master's degree.
• Experience in biotech or pharmaceutical industries with a focus on packaging/labeling.
• Strong knowledge of cGMPs and Health Authority Regulations.

Responsibilities

• Lead QA support for deviations and change control management.
• Provide guidance on quality systems usage and best practices.
• Perform clinical and commercial labeling review and approval.

Skills

Quality Systems Management

Risk Management

Regulatory Compliance

Pharmaceutical Industry Knowledge

Project Management

Education

BS/BA in Biology or related field

MS/MA in Biology or related field

Job description

Exelixis Inc in Alameda, California, is seeking an Associate QA Operations Director to provide quality assurance leadership for labeling and systems. The role requires extensive experience in the pharmaceutical industry, ensuring compliance with quality standards and managing complex quality events.

Key responsibilities include overseeing deviation management and ensuring the effectiveness of quality systems. The ideal candidate will possess a strong educational background in Biology or related fields and have a proven track record in risk management and regulatory compliance.