Associate Director, Quality Compliance

The Associate Director of Quality Compliance will optimize and ensure the execution of quality processes and systems, collaborating with cross-functional teams to support GMP development and commercial launch activities. This role involves leading various aspects of Cytokinetics Quality Compliance, maintaining an effective function to ensure adherence to GMP/GDP regulations, and overseeing the GMP supplier quality program, including evaluations, risk assessments, qualifications, audits, and quality agreements. Responsibilities also include leading GMP/GDP and GxP computerized system supplier audits, ensuring quality agreement negotiations meet expectations and comply with regulations, maintaining supplier quality records, and advising management on regulatory surveillance. Additionally, the position supports inspection readiness for anticipated regulatory inspections and partner audits, monitors CMOs and contract labs for inspection status, and provides support for cross-functional teams and training. The role involves supporting the Quality Risk Management program, establishing and improving policies and systems for GMP activities oversight, providing technical support for investigations and training, developing and interpreting program metrics, representing Quality in cross-functional teams, and staying current with GxP regulations, providing impact assessments and recommendations for new requirements.