Executive Director, Global GCP QA
Structure Therapeutics
12 hours ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary:
- Ensure all clinical studies comply with global regulations and guidelines (FDA, EMA, NMPA, ICH), covering sponsor and outsourced clinical trial activities. Promote GCP understanding to ensure patient safety and data integrity.
Job Responsibilities:
- Act as primary GCP QA subject-matter expert and point of contact for GCP/PV matters.
- Ensure ongoing trials comply with global regulations/guidelines.
- Develop/support quality audit strategy (investigator site audits, Vendor/CRO audits).
- Provide quality oversight and GCP guidance to clinical teams and CROs/vendors for ICH GCP and regulatory compliance.
- Evaluate IND/IMPD/NDA-enabling documentation, study processes, and operational plans for regulatory alignment.
- Serve as final quality decision authority for critical deviations, investigations, and GCP quality risk management (risk-based thinking).
- Establish meeting cadence with Clinical Development Operations; correct issues early.
- Partner with clinical functions to implement fit-for-purpose GCP procedures.
- Manage vendor risks to support compliance, data integrity, and participant safety.
- Create/maintain GCP QMS documentation (SOPs, manuals, templates, process maps, approval flows); report quality metrics.
- Lead inspection readiness and support regulatory/partner audits.
- Promote quality via communication, training, and stakeholder engagement.
Qualifications:
- BS (scientific discipline) required; MS/PhD preferred.
- Auditor certifications required; SQA RQAP GCP credentials preferred.
- 15+ years Clinical Quality Assurance experience in global pharma/biotech/CRO; 5+ years overseeing outsourced trials and direct GCP auditing.
- Proven leadership in GCP regulatory inspections.
- Expertise: GCP and ICH E6(R3); knowledge of 21 CFR Part 11/EU Annex 11; pharmacovigilance a plus.
- Experience implementing eQMS and eDMS.
Key Skills:
- Strong leadership, project management, communication; strategic planning; highly organized/detail-oriented; ability to prioritize in a fast-paced environment; contemporary GCP knowledge.
Benefits:
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical/dental/vision insurance; 401k match; unlimited PTO; paid holidays (including winter shutdown).
Application Instructions:
- Apply via the official career page at BambooHR.
- Ensure all clinical studies comply with global regulations and guidelines (FDA, EMA, NMPA, ICH), covering sponsor and outsourced clinical trial activities. Promote GCP understanding to ensure patient safety and data integrity.
Job Responsibilities:
- Act as primary GCP QA subject-matter expert and point of contact for GCP/PV matters.
- Ensure ongoing trials comply with global regulations/guidelines.
- Develop/support quality audit strategy (investigator site audits, Vendor/CRO audits).
- Provide quality oversight and GCP guidance to clinical teams and CROs/vendors for ICH GCP and regulatory compliance.
- Evaluate IND/IMPD/NDA-enabling documentation, study processes, and operational plans for regulatory alignment.
- Serve as final quality decision authority for critical deviations, investigations, and GCP quality risk management (risk-based thinking).
- Establish meeting cadence with Clinical Development Operations; correct issues early.
- Partner with clinical functions to implement fit-for-purpose GCP procedures.
- Manage vendor risks to support compliance, data integrity, and participant safety.
- Create/maintain GCP QMS documentation (SOPs, manuals, templates, process maps, approval flows); report quality metrics.
- Lead inspection readiness and support regulatory/partner audits.
- Promote quality via communication, training, and stakeholder engagement.
Qualifications:
- BS (scientific discipline) required; MS/PhD preferred.
- Auditor certifications required; SQA RQAP GCP credentials preferred.
- 15+ years Clinical Quality Assurance experience in global pharma/biotech/CRO; 5+ years overseeing outsourced trials and direct GCP auditing.
- Proven leadership in GCP regulatory inspections.
- Expertise: GCP and ICH E6(R3); knowledge of 21 CFR Part 11/EU Annex 11; pharmacovigilance a plus.
- Experience implementing eQMS and eDMS.
Key Skills:
- Strong leadership, project management, communication; strategic planning; highly organized/detail-oriented; ability to prioritize in a fast-paced environment; contemporary GCP knowledge.
Benefits:
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical/dental/vision insurance; 401k match; unlimited PTO; paid holidays (including winter shutdown).
Application Instructions:
- Apply via the official career page at BambooHR.