Director, GCP Quality Assurance

Primary Responsibilities
- Plan, schedule, conduct, and manage internal/external GCP audits of CSPs, CROs, investigator sites, and vendors to ensure compliance with company standards and global GCP regulations
- Prepare/review/finalize audit reports; document observations, risks, and corrective actions; track to resolution
- Develop/review/maintain GCP Quality Agreements with CROs, CSPs, and clinical study partners
- Maintain GCP audit metrics and provide quality/compliance reporting for management reviews, inspection readiness, and continuous improvement
- Develop/review/maintain GCP audit SOPs and quality documents
- Manage the internal GCP audit program (planning, execution, follow-up, effectiveness assessments)
- Support mock and regulatory inspections and related quality system responses
- Provide GCP compliance guidance to cross-functional stakeholders; ensure alignment with FDA, ICH, EU, and other global requirements
- Recommend and implement improvements to GCP quality systems, processes, and procedures

Qualifications (Education/Experience/Requirements)
- Bachelor’s degree in Life Sciences (or related) or equivalent combination of education and relevant experience
- 10+ years in pharmaceutical/biotech/regulated industry
- 5+ years in GCP Quality Assurance, compliance, and auditing
- Lead Auditor experience for internal/external GCP audits
- Strong knowledge of ICH-GCP and applicable FDA/EU/international GCP regulations

Preferred Qualifications
- SQA/ASQ/Lead Auditor certification
- Global audit experience across US/EU/UK/Japan/other regions
- Experience with CRO/clinical service providers (eCOA, CSV, data management)

Compensation/Benefits (as stated)
- Salary range: $165,900–$207,400 USD
- Eligible for discretionary bonus and equity awards
- Medical, dental, vision; 401(k) match 1:1 up to 5%; 15+ vacation days; 10 days paid sick time; paid parental leave; tuition assistance