Associate Director, Clinical Quality Assurance Auditor

Cytokinetics

6d•Remote

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, Clinical Quality Assurance (CQA) Auditor will serve as the primary auditor for GCP/GLP/GVP audits and primary process owner of the CQA audit program. 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 leading and conducting internal and external audits, representing CQA during inspection readiness 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

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.
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

Auditor certification is preferred.
Experience in managing or supporting clinical trial or Drug Safety-related regulatory inspections a plus.

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.