Associate Director, Clinical Quality Assurance Auditor

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!

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.

Qualifications

• 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.
• Auditor certification is preferred.
• Up to 60% travel may be required.
• Experience in managing 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.
• Other duties as assigned.
  
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Pay Range:

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.  

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications

• We will never request personal information such as banking details until after an official offer has been accepted and verified

• We will never request that you purchase equipment or other items when interviewing or hiring

• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer