Associate Director, GVP Quality Assurance

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.

As the Associate Director, Good Pharmacovigilance Practice (GVP) Quality Assurance, you are a key member of the Clinical Quality team representing Clinical QA in cross functional setting, and advising Cytokinetics Drug Safety and Pharmacovigilance teams on GVP matters. This role will liaise and interface with internal and external stakeholders to assess and support GVP compliance with local, GVP guidelines and applicable regulations to drive and maintain quality standards and regulatory compliance culture at Cytokinetics.  The ideal candidate has a quality mindset in global clinical development and oversees quality activities including but not limited to representing QA on clinical study teams, inspection readiness, internal and external audits with a proven ability to manage multiple complex projects.  You will lead, execute and manage GVP QA activities while being an advocate to driving quality and regulatory compliance culture at Cytokinetics.

This is an excellent opportunity to help enhance quality culture while having a direct impact on our late and early-stage clinical trials that are the future of Cytokinetics growth!

Responsibilities

Responsibilities include QA Lead to ensure Good Pharmacovigilance Practice (GVP) compliance and the quality of all deliverables including:

• Develop, implement, and maintain the Pharmacovigilance Quality Management System (PV QMS) ensuring alignment with global regulatory requirements (ICH, FDA, EMA, etc.)

• Establish and oversee quality standards, processes, and procedures for all safety surveillance activities related to investigational drugs

• Ensure the PV QMS supports corporate compliance with domestic and international adverse event reporting requirements

• Develop and maintain audit programs for clinical trial safety activities, CRO and other external partners

• Plan and conduct PV audits of pharmacovigilance vendor, internal processes, systems, and documentation to ensure compliance with SOPs and regulatory requirements

• Oversee validation and ongoing compliance of the electronic adverse event database used for tracking, storing and reporting serious adverse events

• Establish quality review processes for adverse event reports (internal and external), expedited safety reports, clinical study report safety sections, and regulatory submissions

• Partner with the Drug Safety and PV on implementation of quality metrics and KPIs to monitor the performance of adverse event reporting activities.

• Review annual safety reports and other safety documentations for quality and compliance

• Develop and oversee quality training programs for internal staff and external CROs on GVP/GCP principles, quality standards, and compliance requirements

• Partner with the Drug Safety & PV to ensure consistent training on drug safety procedures with quality oversight

• Implement risk-based quality management approaches for pharmacovigilance activities

• Lead quality improvement initiatives to enhance the efficiency and effectiveness of safety surveillance operations

• Monitor industry trends, regulatory updates, and best practices to ensure the PV QMS remains current

• Provide GVP QA oversight of the development of all pharmacovigilance SOPs, work instructions and quality records

• Manage and maintain the Quality Event and CAPA system for pharmacovigilance, tracking issues from identification through closure

• Foster a culture of quality awareness and continuous improvement within the pharmacovigilance function

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Qualifications

• Bachelor’s degree in life sciences with 10+ years of progressive global quality/regulatory compliance background in pharma/biotech or medical device industries, with a hands-on role in clinical quality operations and quality system preferred

• Current and strong working knowledge, interpretation/implementation United States Code of Federal Regulations and European regulations and guidance, including ICH-GCP Guidance requirements governing clinical research conduct a