This range is provided by Meet Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$200,000.00/yr - $240,000.00/yr
Additional compensation types
- Annual Bonus
- Direct message the job poster from Meet Life Sciences
Recruiter - Medical Device, Biotech, & Pharma
Summary
A small, clinical-stage biotech company focused on developing therapies for immunological diseases and cancer is seeking a Director, GCP Quality Assurance . This role will lead the global GCP and Pharmacovigilance (PV) quality strategy, providing oversight across all phases of clinical development. Reporting to the Head of Quality Assurance, the Director will be responsible for inspection readiness, risk management, and fostering a strong culture of compliance and operational excellence across internal teams and external partners.
Responsibilities
- Lead risk-based GCP and PV QA oversight for clinical trials from first-in-human through marketing authorization
- Partner with Clinical Development, Clinical Operations, Pharmacovigilance, and Regulatory teams to provide compliance guidance and support for trial design, protocol development, and vendor selection
- Implement and maintain a risk-based audit program covering clinical sites, vendors, internal systems, and service providers
- Manage and/or conduct GCP and PV audits, including overseeing corrective and preventive actions (CAPAs)
- Provide leadership in preparing for and managing regulatory inspections and inspection strategies
- Contribute to the development, review, and improvement of GCP/PV policies, SOPs, and other quality system documents
- Ensure quality systems and processes are in place to safeguard the rights, safety, and well-being of clinical trial participants
- Collaborate cross-functionally with internal stakeholders and external partners to support a strong culture of compliance
- Monitor quality trends, deviations, and risk indicators and present insights and performance updates to senior leadership
Qualifications
- Bachelor’s or advanced degree in Biology, Chemistry, Chemical Engineering, or related field
- Minimum 10 years of experience in the biopharmaceutical industry with a strong focus on GCP Quality Assurance, ideally in a small biotech or pharma setting
- Proven track record of leading GCP QA strategy and operations across all phases of clinical development
- Experience preparing for and managing global regulatory authority inspections (FDA, EMA, MHRA, PMDA, etc.)
- Extensive experience with internal and third-party GCP audits, issue management, and CAPA oversight
- In-depth knowledge of ICH GCP, global regulatory requirements, and industry best practices
- Experience building and maintaining quality systems and SOPs to support GCP and PV compliance
- Strong leadership and collaboration skills across internal teams and external partners/vendors
- Excellent communication and presentation skills with experience engaging senior leadership
- Ability to balance strategic thinking with hands-on execution in a dynamic, fast-paced environment
Seniority level
Director
Employment type
Full-time
Job function
Quality Assurance
Note: This job description has been refined to remove extraneous content while preserving core responsibilities and qualifications.
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