Cytokinetics is seeking a highly motivated individual to join our team as Associate Director, Quality Systems. You will have the opportunity to create and ensure quality processes and systems are optimized and carried out appropriately to support GMP development and commercial activities for our first product launch!  You will lead various aspects of the Quality Systems, and ensure compliance with company’s procedures, company policies, and regulatory guidelines.

Responsibilities

• Design, develop and deploy quality systems in accordance with ICH Q10 model
• Contribute to the strategic roadmap for the Quality Systems group
• Share strategic responsibility for management of quality systems, including but not limited to Quality Event management, Quality governance boards, Quality risk management program, continuous improvement projects
• Ensure that quality systems are designed and operate as appropriate to provide support in development and commercialization for GXP areas
• Define strategy and execute continuous improvement opportunities within Quality Systems
• Assess Quality Management System processes for potential gaps and remediation to ensure compliance with regulatory guidelines
• Act as subject matter expert and provide guidance and training on quality events, including but not limited to change control, deviations, investigations, and CAPAs
• Lead investigations and utilize root cause analysis methodologies
• Establish and implement risk management program
• Own and drive completion of Quality Systems deviations, CAPAs, and change controls
• Lead quality governance board meetings, including deviation/CAPA, change control, and quality review boards
• Establish metrics and report out to management and cross-functional areas to ensure routine monitoring of quality system health
• Oversee and manage the electronic quality management system, including workflow configuration and upgrades, as needed
• Be the SME and represent Quality on cross-functional teams
• Participate in audits and inspections representing Quality Systems
• Supervise employees, consultants/contractors, and interns
• Support departmental budget planning
• Other duties, as assigned by management

Qualifications

• Bachelor’s degree in a scientific field, with 10+ years experience in a biopharmaceutical, pharmaceutical, biologics, or related life sciences area and relevant Quality Systems experience
• Knowledge of GXP regulations and guidelines, as it pertains to Quality Systems
• Ability to work with ambiguity, creative approach to problem solving and ability to define a clear path forward with emphasis on keeping things simple
• Ability to work effectively with various technical groups and a strong working knowledge in the following disciplines: API or DP manufacturing, analytical development/QC
• Ability to work in a collaborative team environment is essential, with a customer-focused approach
• Strong decision maker with the ability to utilize critical thinking to problem-solve
• Must have strong interpersonal and communication skills
• Experience writing, reviewing and editing SOPs, as well as other document types