Director, QA Operations

Cytokinetics•Radnor, PA

3d•€122,300 - €163,000•Hybrid

About The Position

Cytokinetics is 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.

Requirements

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
Organized and adaptable with strong interpersonal skills
Demonstrated intuition as a result of experience working through complex

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.