Responsibilities

• Provide GMP Quality Assurance oversight for clinical and commercial manufacturing, and distribution activities performed at Contract Manufacturing Organizations (CMOs).
• Perform Quality review of clinical and commercial batch records and supporting documentation to ensure compliance with cGMP requirements, approved manufacturing instructions and regulatory filings.
• Review manufacturing, and testing documentation to support batch disposition and product release.
• Review and approve deviations, investigations, CAPAs, change controls and associated Quality Management System records to ensure timely resolution and appropriate root cause analysis.
• Assess quality events for potential product impact and support risk-based quality decisions.
• Provide Quality support for technology transfers, process validation, engineering batches, process performance qualification (PPQ) and commercial launch activities.
• Review and approve GMP documentation including Standard Operating Procedures (SOPs), Master Batch Records, specifications, protocols, reports and work instructions.
• Participate as the Quality representative on cross-functional teams supporting clinical and commercial programs.
• Support implementation of manufacturing, packaging and process improvements through the change management process.
• Ensure compliance with Cytokinetics Quality Management System requirements, cGMP regulations and applicable global regulatory expectations.
• Support qualification and ongoing Quality oversight of CMOs, contract laboratories and other GMP service providers.
• Participate in internal audits, supplier audits and regulatory inspections, including inspection readiness activities and support for responses to audit observations.
• Support Product Quality Reviews (PQRs), Annual Product Reviews (APRs), Quality Management Reviews and Quality Metrics reporting.
• Collaborate with Regulatory Affairs, Technical Operations, Supply Chain and Manufacturing partners to support CMC submissions, post-approval changes and regulatory commitments.
• Maintain GMP documentation and Quality records within the electronic Quality Management System (eQMS).
• Identify opportunities to improve Quality Systems and GMP processes and participate in continuous improvement initiatives.
• Provide guidance to internal stakeholders and external partners on GMP quality requirements.
• Perform other Quality Assurance duties as assigned to support business objectives.
•