Senior GCP Quality Assurance Lead

Job Summary

Leading GCP quality assurance efforts, the full-time Senior GCP Quality Assurance Lead will provide end-to-end oversight for clinical programs, ensuring compliance with regulatory requirements while supporting quality activities across pharmacovigilance and pre-clinical areas in a remote setting.

Key responsibilities:

• Act as the primary QA lead for clinical programs, overseeing GCP compliance from study initiation to inspection readiness
• Manage preparation for global regulatory inspections and coordinate responses to inspection findings
• Conduct audits of clinical sites and vendors, ensuring adherence to quality standards and implementing corrective actions

Required qualifications:

• Bachelor's degree or higher in Life Sciences, Pharmacy, or a related discipline
• Extensive experience in GCP Quality Assurance within biotech, pharmaceutical, or CRO environments
• Strong knowledge of GCP, GVP, and GLP frameworks, along with ICH guidelines and global regulatory requirements
• Proven experience leading or supporting regulatory inspections
• Experience with eTMF systems and electronic QMS platforms