Cytokinetics · 2 days ago
Director, Quality Operations
San Francisco Bay Area
Full-time
Onsite
Director/Executive
$216K/yr - $252K/yr
7+ years expCytokinetics is a specialty cardiovascular biopharmaceutical company focused on pioneering scientific innovations in muscle biology. They are seeking a Director of Quality Assurance to oversee Quality Control activities, ensuring compliance and data integrity in support of GMP development and commercial activities for their product launch.
BiopharmaBiotechnologyHealth Care
Responsibilities
Provide strategic leadership and quality governance for QC data oversight programs, establishing standards to ensure global compliance, accuracy, and data integrity
Lead QA oversight for product stability and lot release programs, ensuring alignment with cGMP, FDA, EMA, and ICH expectations
Develop, implement, and continuously improve governance frameworks for analytical data review and trending across internal teams and CMOs
Direct QA review strategies for critical QC deliverables, including analytical trends, OOS and OOT investigations, and product shelf-life assessments
Chair or co-lead cross-functional forums to ensure proactive identification and mitigation of analytical or stability risks
Provide final QA endorsement for CoAs to support product disposition decisions. Ensure robust processes are in place for review and approval by QA
Oversee QA partner engagement with CMOs and testing laboratories to ensure alignment with quality agreements, stability plans, and regulatory guidelines
Serve as subject matter leader in QA oversight of data review, stability programs, and batch release data, with the potential opportunity to build and mentor a team as the function expands
Guide cross-functional teams in readiness for global regulatory inspections; act as primary QA representative and SME in data integrity, and stability and batch release data compliance
Collaborate with Regulatory Affairs and Technical Operations to support CMC submissions and responses to health authority queries related to analytical data
Oversee monitoring and reporting of stability metrics and quality performance indicators to senior leadership
Lead continuous improvement initiatives to strengthen QA oversight processes and analytical data life-cycle management
Qualification
Required
Bachelor's Degree in a scientific or technical discipline with 7+ years' experience in the biopharmaceutical or pharmaceutical industry with at least 5 years of experience within QA/QC
Ability to work in a collaborative team environment is essential
Experience with clinical/ commercial QC / stability programs
Knowledge of US and EU cGMP regulations/guidance
Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
Effective communication skills, both verbal and written
Must have strong analytical and interpersonal communication skills
Experience writing, reviewing and editing SOPs and specifications
Knowledge of pharmaceutical regulations within the US (FDA) and Europe (EMA) required
Preferred
Advanced degree (MS, PhD) is a plus
Experience using electronic Quality Management Systems is a plus
Additional knowledge of other ROW regulations a plus
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
Medical Xpress - latest medical and health news stories
2026-01-06
Company data provided by crunchbase