Cytokinetics · 2 weeks ago
Associate Director, GVP Quality Assurance
San Francisco Bay Area
Full-time
Hybrid
Lead/Staff, Director/Executive
$206K/yr - $228K/yr
10+ years expCytokinetics is a specialty cardiovascular biopharmaceutical company focused on scientific innovations in muscle biology. The Associate Director, GVP Quality Assurance will lead and manage GVP compliance activities, ensuring quality standards and regulatory compliance in clinical trials.
BiopharmaBiotechnologyHealth Care
Responsibilities
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
Qualification
Required
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
Preferred
Auditor certifications a plus
Experience in hosting or supporting clinical trial or Drug Safety-related regulatory inspections a plus
Up to 10% travel may be required
Other duties as assigned
Company
Cytokinetics
Cytokinetics is a biopharmaceutical company developing therapies for debilitating diseases.
501-1000 employees
H1B Sponsorship
Cytokinetics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (9)
2023 (4)
2022 (6)
2021 (7)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$2.41BKey Investors
Royalty PharmaDeerfieldVulcan
2025-09-16Post Ipo Debt· $650M
2024-05-22Post Ipo Equity· $550M
2024-05-22Post Ipo Debt· $50M
Leadership Team
Robert Blum
President & CEO
Sung Lee
EVP & CFO
Recent News
GlobeNewswire
2026-01-13
Medical Xpress - latest medical and health news stories
2026-01-06
Company data provided by crunchbase