Associate Director, Quality Compliance

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

As an Associate Director of Quality Compliance, this position will create and ensure quality processes and systems are optimized and carried out appropriately, working with cross-functional teams to support GMP development activities and commercial activities for product launch. The Associate Director will lead various aspects of Cytokinetics Quality Compliance, maintain an effective quality compliance function to ensure adherence to applicable GMP/GDP regulations. The Associate Director will be mainly responsible for ensuring compliance of the GMP supplier quality oversight program, including evaluation and risk assessment, qualification and routine audits, and supplier quality agreements.

Responsibilities

• Supplier Quality Oversight

  • Lead the GMP/GDP and GxP computerized system supplier quality oversight program, ensuring requirements, plans, processes, templates, metrics and tracking system are established and maintained. Ensure audits are performed using internal and external resources and appropriately leveled to the services being performed. Oversee the program to readily determine its health and mitigate supplier and/or program risks in relation to other quality systems and materials/products based on the available information.

  • Lead GMP/GDP and GxP computerized system supplier audits to ensure compliance with the supplier quality oversight program.

  • Ensure quality agreement negotiations with GMP suppliers meet Cytokinetics expectations, are current, and in compliance with industry regulations.

  • Maintain supplier quality records, including audit agendas, reports, associated CAPAs, and quality agreements.

  • Provide periodic updates and advise management of any relevant regulatory surveillance in a timely manner.

• Inspection Readiness

  • Support preparation of anticipated regulatory inspections (PAI, routine inspections, including those at contracted organizations), and partner audits with cross-functional teams.

  • Support GMP/GDP suppliers during inspections of those facilities/sites by regulatory authorities with cross-functional teams and ensure timely updates to management.

  • Monitor CMOs, contract testing labs, and other critical suppliers for regulatory inspection status.

  • Support cross-functional teams and training of team members in preparation of partner audits and inspections.

• General Quality Compliance

  • Support the Quality Risk Management program to ensure activities and processes operate effectively

  • Establish and improve policies, procedures and systems that enable clear oversight of internal and external GMP activities.

  • Provide technical support with ad hoc investigations and/or targeted training as needed.

  • Develop meaningful metrics and interpret results to understand the health programs/systems in relation to other quality programs/systems.

  • Participate in cross-functional teams representing Quality as appropriate.

  • Stay current with GxP regulations, guidelines and industry practices and provide timely updates to cross-functional teams, as necessary. Provide impact assessments of changes to regulations and make recommendations for meeting new requirements.

Qualifications

• A minimum of a bachelor's degree in a scientific field or equivalent.

• 10+ years experience in a biopharmaceutical, pharmaceutical, biologics, or related life sciences area in Quality Compliance.

• Strong experience in performing supplier audits (GMP manufacturing, laboratories, warehouse and distribution, validation, computerized systems), including effective auditing techniques and generation of documentation is required; ASQ certification is a plus; 5+ years direct GMP auditing experience preferred.

• Strong working knowledge and interpretation/implementation of GMP/GDP regulations, familiarity with worldwide regulatory guidelines is required.

• Experience dealing with regulatory authority inspections is required.

• Proven management skills with the ability to lead and mentor others effectively and experience with advocating for a compli