QA Operations Director: GMP Oversight & Inspections

Cytokinetics; San Francisco, Northern (CA, KY); Hybrid; USD 222,000 - 260,000; Full time

Job summary

Cytokinetics is seeking a Director, QA Operations to lead QA oversight of Drug Substance and Drug Product manufacturing and testing, including on-site support at CMOs. You will review batch records, analytical data, and CAPAs, ensuring delivery of compliant products.

You will partner with Regulatory Affairs, Technical Operations, and Supply Chain to maintain global GMP compliance and support inspections, PQRs, and continuous improvement across development and commercial programs.

Qualifications

• Bachelor's degree in a scientific or related field.
• 10+ years in pharmaceutical manufacturing or QA.
• Experience hosting regulatory inspections and/or client audits.
• Strong leadership and staff development skills.
• Proficient knowledge of global regulatory requirements.

Responsibilities

• Provide QA oversight of DS and DP manufacturing and testing activities.
• Lead QA staff and coordinate with CMOs, CTLs, and internal QA teams.
• Review and approve batch records, specifications, and GMP documentation.
• Lead regulatory inspections, partner audits, and internal assessments.
• Drive continuous improvement and quality metrics across sites.

Skills

Team leadership

Quality systems

GxP / GMP knowledge

Regulatory inspections

Manufacturing oversight

Documentation

Education

Bachelor's degree

Tools

MS Office

Job description

Cytokinetics is seeking a Director, QA Operations to lead QA oversight of Drug Substance and Drug Product manufacturing and testing, including on-site support at CMOs. You will review batch records, analytical data, and CAPAs, ensuring delivery of compliant products.

You will partner with Regulatory Affairs, Technical Operations, and Supply Chain to maintain global GMP compliance and support inspections, PQRs, and continuous improvement across development and commercial programs.