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 regulations. The Associate Director will be responsible for ensuring compliance of the GMP supplier quality program, including qualification and routine audits, and supplier quality agreements, and maintaining programs/systems led by the Quality Compliance group, such as the product complaint program, product recall program, inspection readiness, and internal audits.

Responsibilities

• Compliance
  • 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/system.
  • Participate in cross-functional teams representing Quality as appropriate.
  • Stay current with GxP regulations, guidelines and industry practices and provide timely updates to management and internal departments. Provide impact assessments of changes to regulations and make recommendations for meeting new requirements.

• Supplier Quality Management
  • Develop/maintain supplier management program, ensuring requirements, plans, processes, templates, metrics and tracking system for GMP suppliers are established and maintained. Ensure audits are performed using internal and external resources.
  • Establish and maintain GMP supplier compliance status across Cytokinetics audits. Provide periodic updates and advise management of any relevant regulatory surveillance in a timely manner.
  • 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.

• Inspection Readiness
  • Lead preparation of anticipated regulatory inspections (PAI, routine inspections, including those at contracted organizations), and partner audits using cross-functional teams.
  • Act as primary contact with GMP suppliers during inspections of those facilities/sites by regulatory authorities and provide timely updates to management.
  • Monitor CMOs, contract testing labs, and other critical suppliers for inspection status.
  • Establish cross-functional teams and training of team members to support audits and inspections.

• Distributed Product
  • Ensure the product complaint program is performing as intended, in compliance with regulations and business needs.
  • Ensure product recall or withdrawal activities, including mock recall, are performed according to protocol.
  • Maintain compliance to FAR/DSCSA and PDMA reporting requirements.

Qualifications

• A minimum of a bachelor's degree in a scientific field or equivalent with 10+ years experience in a biopharmaceutical, pharmaceutical, biologics, or related life sciences area with experience in Quality Compliance.
• Experience in auditing techniques (ASQ certification is a plus).
• Strong working knowledge and interpretation/implementation of GMP regulations, familiarity with worldwide regulatory guidelines.
• 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 compliant environment.
• Ability to work effectively with various technical groups and a strong working knowledge in the following disciplines: API or drug product manufacturing, analytical development/QC, product launch activities, clinical and commercial distribution channels.
• Ability to work in a collaborative team environment is essential, with a customer focused approach. Must have strong interpersonal and communication skills.
• Strong decision maker with the ability to utilize critical thinking to problem-solve.
• Ability to work with ambiguity, creative approach to problem solving and ability to define a clear path forward with emphasis on keeping things simple.
• Experience writing, reviewing and editing SOPs, specifications, and validation documentation as well as other document types.