Define and drive a strong GCP quality culture across clinical programs.
Oversee clinical quality systems and metrics, anticipate and escalate risk before it becomes an issue.
Work with Clinical Operations, Regulatory, Safety, and other partners to keep trials inspection-ready.
Support and develop Clinical Quality team members guiding inspection readiness, deviations, investigations, audits, and CAPAs.
Shape an integrated, proactive clinical quality strategy that scales with the pipeline.
Develop and report key quality metrics across all clinical programs and trials.
Assess current-state quality across programs, processes, and trials.
Identify trends, risks, and lead process and system improvements.
Ensure compliance with GCP, ICH-GCP, FDA, EMA, PMDA, and applicable regulations.
Author standard operating procedures and related documents.
Monitor regulatory changes and assess impact to programs.
Provide guidance and mentorship to clinical quality staff assigned to clinical programs and supporting study teams.

Requirements

Bachelor’s degree in a scientific field required; advanced scientific degree a plus  .
10+ years industry experience directly managing GCP/GPvP QA activities, audits, inspections, CAPAs, and risk management.
Must have worked within Sponsor organization although can be in combination with academic and/or CRO experience  .
In-depth knowledge of quality, compliance, risk management, clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirements  .
Experience mentoring and directing members of quality and clinical operations teams  .
Experience working in a team across multiple functional areas (e.g., CMC / GMP Quality, Data Management, Biostats, Safety, Clinical Supply)  .
Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit  .
Ability to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to create solutions and enable decisions  .
Self-motivated and able to work autonomously, as well as a member of a high-functioning and collaborative team  .

Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

GCPGPvP QAauditsinspectionsCAPAsrisk managementclinical trial operationsquality metricsstandard operating proceduresregulatory compliance

mentoringguidancecritical thinkingproblem solvingintellectual curiosityinnovationself-motivatedcollaborationleadershipcommunication