Cytokinetics · 20 hours ago
Associate Director, Clinical Quality Assurance Auditor
United States
Full-time
Remote
Lead/Staff, Director/Executive
$195K/yr - $228K/yr
10+ years expCytokinetics is a specialty cardiovascular biopharmaceutical company focused on scientific innovations in muscle biology. The Associate Director, Clinical Quality Assurance Auditor will be responsible for leading GCP/GLP/GVP audits and managing the CQA audit program to ensure quality and regulatory compliance across clinical trials.
BiopharmaBiotechnologyHealth Care
Responsibilities
Serve as the CQA audit program process owner and accountable for the day-to-day activities of the audit program, including audit coordinating, report reviews, response review, and CAPA follow up, and audit closures
Serve as the principal lead auditor for GCP, GVP, and GLP audits, including investigator sites, CROs, vendors, laboratories, and internal functional areas. develop, implement, and maintain a risk-based global clinical audit program, ensuring comprehensive coverage of company-sponsored trials and critical vendors
Analyze and manage audit program metrics, trends to identify key compliance risks and improvement opportunities; communicate findings to senior management
Lead inspection readiness activities for global health authority inspections, including mock inspections, SME training and preparation, and documentation review
Assist with the design and the creation/management/maintenance of quality plans and metrics
Oversee and coordinate with contract auditors on internal and external quality audits of clinical vendors and investigator sites
Assist with quality review of key clinical documents (e.g. clinical protocol, ICFs, CSRs, case report form) and clinical SOPs
Design and conduct GCP Training for functional departments, act as the primary trainer for the auditor program
Support maintenance and continuous improvement of the clinical quality management system (QMS), including SOPs, training, and compliance metrics
Provide mentoring and oversight to QA staff and foster a culture of quality and accountability across clinical teams
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
Other CQA duties as assigned by management
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 quality audits 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
Up to 60% travel may be required
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
Preferred
Auditor certification is preferred
Experience in managing or supporting clinical trial or Drug Safety-related regulatory inspections 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
GlobeNewswire
2026-01-13
Company data provided by crunchbase