Associate Director, GVP Quality Assurance

Cytokinetics, Incorporated • South San Francisco, CA

82d • $162,800 - $271,300 • Hybrid

About The Position

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. As the Associate Director, Clinical Quality Assurance (CQA), you are a key member of the Clinical Quality team maintaining representing Clinical QA in cross functional setting, and advising Cytokinetics Clinical Operations, Biometry and Drug Safety and Pharmacovigilance teams on Clinical Quality matters. This role will liaise and interface with internal and external stakeholders to assess and support GCP compliance with local, ICH-GCP 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 inspection readiness, internal and external audits with a proven ability to manage multiple complex projects. You will lead, execute and manage Clinical QA activities while being an advocate to drive 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

• B.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.
• Auditor certifications a plus.
• Up to 10% travel may be required.
• Experience in hosting or supporting clinical trial or Drug Safety-related regulatory inspections a plus.
• Ability to lead cross-functional teams, independently prioritize work and manage multiple priorities while maintaining quality and GCP compliance objectives.
• Ability to use expertise and skills to contribute and achieve Cytokinetics' company objectives and principles in creative and effective ways.

Nice To Haves

• Other duties as assigned.

Responsibilities

• Provide CQA oversight to Phase I-III global clinical studies to ensure study conduct compliance in accordance with GCP, applicable regulatory requirements, study protocols and Cytokinetics procedures.
• Accountable for inspection readiness activities including collaborating with cross functional and clinical site Inspection Readiness/Preparedness activities.
• Provide expert CQA advice and strategic mentorship to stakeholders (e.g. Clinical Operations, Data Management, Pharmacovigilance) to support regulatory inspections.
• Design and implement the creation/management/maintenance of quality plans and metrics.
• Collaborate with staff conducting internal and external quality audits of clinical vendors and investigator sites.
• Perform quality review of key clinical documents (e.g. clinical protocol, ICFs, CSRs, case report form) and clinical SOPs.
• Coordinate and provide GCP Training for functional departments.
• Represent CQA in assigned projects and study/program team meetings to address quality issues that may arise, including identification and resolution and be an advocate for quality and regulatory compliance.

Benefits

• In the U.S., the hiring pay range for fully qualified candidates is $162,800 - $271,300 per year.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees