Senior Quality Assurance Specialist - Drug Product

Cytokinetics seeks a Senior Quality Assurance Specialist for Drug Product to oversee batch documentation review and GMP compliance activities for contract manufacturing operations. The role involves managing quality issues, supporting regulatory inspections, and collaborating across functions to ensure product quality and regulatory adherence.

Responsibilities

• Provide GMP Quality Assurance oversight for clinical and commercial manufacturing at CMOs
• Review batch records and supporting documentation for cGMP compliance and approved procedures
• Review and approve deviations, investigations, CAPAs, and change controls with root cause analysis
• Support technology transfers, process validation, and commercial launch activities
• Participate in audits, regulatory inspections, and cross-functional teams supporting manufacturing programs

Requirements

• Bachelor's degree in scientific, engineering, or technical discipline
• Minimum 5 years biopharmaceutical/pharmaceutical industry experience; 3+ years in GMP Quality Assurance
• Experience with oral solid dose manufacturing and packaging processes
• Knowledge of US FDA, EU EMA, and ICH cGMP regulations
• Experience reviewing batch documentation and managing deviations, investigations, and CAPAs
• Proficiency with electronic Quality Management Systems such as Veeva Quality or TrackWise
• Strong communication and organizational skills with ability to manage multiple priorities

Compensation: $134,100-$156,450 base salary