Associate Director, Clinical Quality Assurance Auditor
Cytokinetics
June 29, 2026
Remote friendly (United States)
United States
$195,300 - $227,850 USD yearly
Operations
Responsibilities:
- Serve as CQA audit program process owner; manage day-to-day audit program activities including audit coordinating, report/response review, CAPA follow-up, and audit closures.
- Act as principal lead auditor for GCP/GVP/GLP audits across investigator sites, CROs, vendors, laboratories, and internal functional areas; develop/implement/maintain a risk-based global clinical audit program covering company-sponsored trials and critical vendors.
- Analyze audit metrics and trends; identify compliance risks/improvement opportunities and communicate findings to senior management.
- Lead global health authority inspection readiness (mock inspections, SME training/preparation, documentation review).
- Assist with design and management/maintenance of quality plans and metrics.
- Coordinate with contract auditors for internal/external quality audits of clinical vendors and investigator sites.
- Support quality review of key clinical documents (clinical protocol, ICFs, CSRs, case report forms) and clinical SOPs.
- Design and conduct GCP training for functional departments; primary trainer for auditor program.
- Support continuous improvement of the clinical QMS (SOPs, training, compliance metrics).
- Mentor/oversee QA staff and foster quality/accountability culture across clinical teams.
- Represent CQA in study/program meetings to resolve quality issues and advocate for quality/regulatory compliance.
Qualifications:
- Bachelor’s degree in life sciences; 10+ years progressive global quality/regulatory compliance experience in pharma/biotech or medical device; hands-on quality audits/quality system preferred.
- Strong knowledge of U.S. CFR and European regulations/guidance, including ICH-GCP and pharmacovigilance operations.
- Experience with electronic Quality Management Systems and Trial Master File.
- Auditor certification preferred.
- Up to 60% travel.
- Experience supporting clinical trial or Drug Safety regulatory inspections is a plus.
- Ability to lead cross-functional teams, prioritize independently, manage multiple priorities, and maintain quality/GCP compliance objectives.
- Serve as CQA audit program process owner; manage day-to-day audit program activities including audit coordinating, report/response review, CAPA follow-up, and audit closures.
- Act as principal lead auditor for GCP/GVP/GLP audits across investigator sites, CROs, vendors, laboratories, and internal functional areas; develop/implement/maintain a risk-based global clinical audit program covering company-sponsored trials and critical vendors.
- Analyze audit metrics and trends; identify compliance risks/improvement opportunities and communicate findings to senior management.
- Lead global health authority inspection readiness (mock inspections, SME training/preparation, documentation review).
- Assist with design and management/maintenance of quality plans and metrics.
- Coordinate with contract auditors for internal/external quality audits of clinical vendors and investigator sites.
- Support quality review of key clinical documents (clinical protocol, ICFs, CSRs, case report forms) and clinical SOPs.
- Design and conduct GCP training for functional departments; primary trainer for auditor program.
- Support continuous improvement of the clinical QMS (SOPs, training, compliance metrics).
- Mentor/oversee QA staff and foster quality/accountability culture across clinical teams.
- Represent CQA in study/program meetings to resolve quality issues and advocate for quality/regulatory compliance.
Qualifications:
- Bachelor’s degree in life sciences; 10+ years progressive global quality/regulatory compliance experience in pharma/biotech or medical device; hands-on quality audits/quality system preferred.
- Strong knowledge of U.S. CFR and European regulations/guidance, including ICH-GCP and pharmacovigilance operations.
- Experience with electronic Quality Management Systems and Trial Master File.
- Auditor certification preferred.
- Up to 60% travel.
- Experience supporting clinical trial or Drug Safety regulatory inspections is a plus.
- Ability to lead cross-functional teams, prioritize independently, manage multiple priorities, and maintain quality/GCP compliance objectives.