Senior Director, GCP Quality Assurance

The role

The Senior Director, GCP Quality Assurance provides strategic leadership and operational oversight for Good Clinical Practice activities. This person will manage GCP quality systems, clinical quality risk management, CRO and vendor oversight, and inspection readiness for clinical development programs.

What you will do

• Define, implement, and mature the GCP QA strategy.
• Serve as the senior GCP QA partner to Clinical Operations and cross-functional stakeholders.
• Build, lead, mentor, and develop GCP QA capability and external QA resources.
• Ensure GCP processes are phase-appropriate, risk-based, and compliant.
• Lead or provide senior QA oversight for GCP-related SOPs, policies, and training materials.
• Provide senior QA oversight for activities conducted by CROs, investigator sites, and vendors.
• Lead GCP vendor qualification, risk-based audit strategy, and vendor governance.
• Review and maintain QA oversight of quality agreements, audit plans, and CAPA commitments.
• Own the risk-based GCP audit program including CRO, site, vendor, and TMF audits.
• Lead GCP inspection readiness, conduct, response development, and follow-up.

Required qualifications

• Bachelor’s degree in a scientific or related discipline
• 12+ years of progressive GCP Quality Assurance or Clinical Quality experience within a biotech, pharmaceutical, or CRO environment
• Significant leadership experience at the Director level or equivalent
• Deep knowledge of global GCP requirements and clinical trial oversight expectations, including ICH E6, FDA regulations, and EU Clinical Trials Regulation
• Demonstrated experience leading or managing GCP audits and regulatory inspections
• Extensive experience overseeing CROs, clinical vendors, and investigator sites
• Experience supporting late-stage, pivotal, or registrational clinical trials
• Strong background in risk-based quality management, ICH E6(R3) risk-proportionate approaches, and quality metrics
• Experience building, scaling, or maturing GCP QA capabilities in lean, virtual, or growing biotechnology organizations
• Executive presence and strong cross-functional influence
• Ability to balance compliance, patient safety, data integrity, and operational execution

Nice to have

• Advanced degree
• Minimum 3 years of people management
• Experience with eTMF, clinical quality systems, and electronic GxP systems
• Familiarity with 21 CFR Part 11, data integrity principles, and Veeva or similar platforms

Benefits

• Competitive health and wellness coverage
• Paid time off
• Public holidays
• Additional leave entitlements in accordance with local requirements
• Flexible work arrangements / hybrid schedule

About the company

Beeline Medicines is a clinical-stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases.