Cytokinetics

Cytokinetics

Associate Director, Clinical Quality Assurance Auditor

Remote, USA · Director

Sponsorship not specified$195k-$228kDetected 91 days ago
GCPComplianceClinical TrialsClinical ResearchPharmacovigilanceMedical DevicesResearchCommunicationMentoring

About the role

  • 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 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!
  • The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

Responsibilities

  • Analyze and manage audit program metrics, trends to identify key compliance risks and improvement opportunities
  • Assist with the design and the creation/management/maintenance of quality plans and metrics.
  • 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.
  • Analyze and manage audit program metrics, trends to identify key compliance risks and improvement opportunities; communicate findings to senior management.

Requirements

  • Experience with electronic Quality Management Systems and Trial Master File.
  • Up to 60% travel may be required.
  • Ability to use expertise and skills to contribute and achieve Cytokinetics' company objectives and principles in creative and effective ways.
  • 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
  • Ability to lead cross-functional teams, independently prioritize work and manage multiple priorities while maintaining quality and GCP compliance objectives.
  • Other duties as assigned.
  • #LI-REMOTE
  • Pay Range:
  • In the U.S., the hiring pay range for fully qualified candidates is $195,300 - $227,850 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
  • 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.

Nice to have

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

Compensation

  • In the U.S., the hiring pay range for fully qualified candidates is $195,300 - $227,850 per year.
  • The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

Benefits

  • Lead inspection readiness activities for global health authority inspections, including mock inspections, SME training and preparation, and documentation review.

Equal opportunity

  • www.cytokinetics.com
  • Cytokinetics is an Equal Opportunity Employer
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This listing is sourced directly from Cytokinetics's careers page and normalized into a canonical job model.