Clinical Quality Compliance Manager

Subject Matter Expert (SME) on the Clinical Quality Compliance activities including deviation management, quality investigation, corrective and preventive actions (CAPA) management and oversight and change control. Represent Clinical Quality Compliance in these topics in inspections.

Engages with relevant functions and stakeholders to ensure inspection readiness, driving accountability and transparency. Functions include, but not limited to, Global Development Office, Data Science Institute, Global Regulatory Affairs, Procurement, Legal, etc.

Strategic thought partner to the Head of GCP Quality Compliance in developing and implementing GCP Compliance strategies, in managing the operational activities of and building capabilities within the GCP Compliance function and in ensuring alignment with the CPMQ vision.

Responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance.

Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.

Development and implementation of a clinical or pharma-covigilance audit program, hosting/leading regulatory inspections and remediation activities on a global level.

Please submit for more detailed JD.

Job Type: Full-time

Pay: $105.87 - $110.06 per hour

Work Location: In person