Associate Director, GVP Quality Assurance

Cytokinetics•South San Francisco, CA

70d•$206,150 - $227,850•Hybrid

About The Position

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!

Requirements

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 and pharmacovigilance operations
Experience with electronic Quality Management Systems and Trial Master File.
Ability to lead cross-functional teams, independently prioritize work and manage multiple priorities while maintaining quality and GCP/GVP compliance objectives.
Ability to use expertise and skills to contribute and achieve Cytokinetics’ company objectives and principles in creative and effective ways.
Other duties as assigned.

Nice To Haves

Auditor certifications a plus.
Experience in hosting or supporting clinical trial or Drug Safety-related regulatory inspections a plus.

Responsibilities

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