Director, QA Operations

Cytokinetics; South San Francisco (CA); On-site; USD 190,000 - 260,000; Full time

Job summary

Cytokinetics, a leader in cardiovascular biopharmaceuticals, seeks a Director, QA Operations to oversee QA for DS/DP manufacturing, testing, and lifecycle management across CMOs and labs. You will lead a team, ensure GMP compliance, and act as a strategic partner with regulatory affairs and manufacturing teams.

The role requires extensive experience in pharmaceutical QA, inspection readiness, and global regulatory knowledge, with the ability to drive continuous improvement and quality excellence

Qualifications

• Bachelor's degree; life sciences preferred
• 10+ years in pharmaceutical manufacturing or related fields
• Experience leading QA teams and coaching staff
• Experience hosting regulatory inspections and/or client audits
• Strong knowledge of global regulations and compliance

Responsibilities

• Lead QA oversight of DS/DP manufacturing and testing activities across CMOs/CTLs
• Provide on-site QA support during manufacturing campaigns
• Review and approve GMP records, batch records, specifications, and quality documents
• Oversee investigations, deviations, CAPAs, change controls, and risk assessments
• Ensure timely identification and resolution of quality issues affecting product quality/supply
• Oversee technology transfers, process validation, and continued process verification
• Partner with stakeholders to drive continuous improvement and operational excellence
• Lead QA aspects during regulatory inspections and audits
• Support Product Quality Reviews and management reviews
• Ensure supplier quality agreements and oversight are effective and compliant

Skills

Team leadership

Quality systems

Regulatory knowledge

Inspection readiness

Continuous improvement

Education

Bachelor's degree (BSc)

Tools

MS Office

Job description

Cytokineticsis a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

Reporting to the Head of Global QA Operations/QP, the Director, QA Operations is responsible for leading Quality Assurance oversight of all Drug Substance (DS) and Drug Product (DP) manufacturing, testing, release, and lifecycle management activities performed by Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), and other GxP service providers.

The Director will lead a team of QA staff responsible for end-to-end quality oversight of clinical and commercial manufacturing operations, including on-site manufacturing support, batch record and analytical data review, disposition of quality events, and approval of GMP quality system records. The role serves as a strategic quality partner to other QA teams, Technical Operations, Supply Chain, Regulatory Affairs, and external partners to ensure compliance with global regulatory requirements and company quality standards.

The Director will be an internal lead SME during inspections for manufacturing and testing QA aspects. They must be knowledgeable and current with the global regulatory environment, as well as assess, and communicate impact of changes on development programs and commercial products.

Key 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

Job Requirements/Qualifications:

• Batchelor’s degree (BSc) minimum preferred
• 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