Note: The job is a remote job and is open to candidates in USA. Cytokinetics is a specialty cardiovascular biopharmaceutical company advancing potential medicines for patients with cardiac muscle dysfunction. The Director, QA Operations will lead quality assurance oversight of drug substance and drug product manufacturing, testing, release, and lifecycle management conducted by external partners, while managing a QA team and ensuring regulatory and GMP compliance. The role also supports inspections, quality systems, technology transfers, investigations, and continuous improvement across clinical and commercial operations.
Responsibilities
- Lead and develop a team responsible for QA oversight of all DS and DP manufacturing and testing activities
- Provide real-time QA support during manufacturing campaigns, including on-site presence at CMOs when required
- Ensure effective oversight of commercial and clinical manufacturing, packaging, labeling, testing, and support release activities
- Review and approve executed batch records, manufacturing documentation, analytical data packages, and associated GMP records to support product disposition and release
- Review and approve master batch records, specifications, protocols, reports, and other GMP-controlled documents
- Review, approve, and oversee investigations, deviations, CAPAs, change controls, risk assessments, and other quality system records
- Ensure timely identification, escalation, investigation, and resolution of quality issues impacting product quality, compliance, or supply
- Provide quality oversight of technology transfers, process validation, process performance monitoring, and continued process verification activities
- Partner with CMOs, CTLs, and internal stakeholders to drive continuous improvement and operational excellence
- Serve as the Quality lead for manufacturing and testing activities during regulatory inspections, partner audits, and internal inspections
- Support Product Quality Reviews (PQRs/APRs), management reviews, and quality metric monitoring
- Ensure quality agreements and supplier oversight activities remain effective and compliant with applicable regulations
- Maintain awareness of evolving global GMP regulations and industry expectations and assess their impact on products, processes, and quality systems
- Foster a culture of quality, accountability, compliance, and continuous improvement
Skills
- Proven experience leading and managing teams, with a strong ability to coach, mentor, and support staff growth and professional development
- Minimum 10 years' experience in Pharmaceutical Manufacturing and related areas
- Experience hosting Regulatory Inspections and/or client/partner audits
- Deep Knowledge of current global Regulations and upcoming changes
- Proficient user of MS Office Package
- Experience interacting, supporting and influencing at all levels across the business
- Proven ability to operate independently with initiative and minimal supervision
- Energetic with the ability to multi-task and prioritize workload
- Excellent written and verbal communication skills
- Organized and adaptable with strong interpersonal skills
- Demonstrated intuition as a result of experience working through complex
- Travel requirements – up to 15% per annum
- Batchelor's degree (BSc) minimum preferred
Benefits
- Equity in the form of stock options and/or restricted stock units
- Comprehensive health, dental, vision, life and disability insurance coverage
- 401k retirement benefits with employer match
- Learning and wellness stipends
- Paid time off
- Benefits are subject to change and may vary based on jurisdiction of employment.
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