Senior Director, GCP Quality Assurance

About the role

Beeline Medicines is seeking a Senior Director of GCP Quality Assurance to lead the strategic and operational oversight of Good Clinical Practice (GCP) quality activities across its clinical development programs. The role ensures that all clinical trials are conducted, documented, and reported in full compliance with regulatory requirements and company standards while maintaining continuous inspection readiness.

Key responsibilities

• Define, implement and continuously mature the GCP QA strategy aligned with clinical development objectives and global regulatory expectations.
• Partner with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, Biostatistics and external service providers to provide strategic guidance on GCP compliance and inspection readiness.
• Lead the development, oversight and improvement of GCP quality risk management, audit strategy, CRO and vendor oversight, and quality metrics.
• Build, mentor and scale a high‑performing GCP QA team and external QA resources.
• Ensure GCP processes are phase‑appropriate, risk‑based, scalable and suitable for outsourced or hybrid clinical models.
• Maintain a proactive culture of quality, patient safety, data integrity and continuous improvement across all clinical programs.

Required profile

• Extensive experience in GCP Quality Assurance within the biotech or pharmaceutical industry.
• Proven leadership of cross‑functional QA initiatives and ability to influence senior stakeholders.
• Demonstrated track record of maintaining inspection readiness and managing CRO/vendor relationships.
• Strong understanding of regulatory requirements and clinical development lifecycle.

Required skills

• Good Clinical Practice (GCP) compliance
• Quality Assurance (QA) methodology
• Clinical quality risk management
• CRO and vendor oversight
• Audit planning and execution
• Inspection readiness