Senior Quality Assurance Specialist - Drug Substance

Cytokinetics seeks a Senior Quality Assurance Specialist for Drug Substance to provide GMP oversight of contract manufacturing operations and review batch documentation for clinical and commercial pharmaceutical products. The role supports quality compliance, regulatory inspections, and cross-functional manufacturing programs.

Responsibilities

• Provide GMP Quality Assurance oversight for clinical and commercial manufacturing at CMOs
• Review batch records and supporting documentation for cGMP compliance and regulatory alignment
• Evaluate deviations, investigations, and CAPAs for timely resolution and root cause analysis
• Support technology transfers, process validation, and commercial product launches
• Participate in audits, regulatory inspections, and cross-functional manufacturing teams

Requirements

• Bachelor's degree in science, engineering, or technical discipline
• Minimum 5 years biopharmaceutical or pharmaceutical industry experience
• At least 3 years in GMP Quality Assurance
• Experience reviewing GMP batch documentation and supporting batch disposition
• Working knowledge of US FDA, EU EMA, and ICH cGMP regulations
• Experience managing deviations, investigations, CAPAs, and change controls
• Proficiency with electronic Quality Management Systems like Veeva Quality or TrackWise

Compensation: $140,400-$163,800 base