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Senior Manager, Quality Management Lead
4 months ago
The Senior Manager, Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide mentorship and leadership for all aspects of quality and compliance. The incumbent will engage with key collaborators, build strategic partnerships working and collaborating closely with study teams, relevant functions and other GDQ functions. Lead risk-based quality activities on all Regeneron-sponsored clinical trials, inclusive of issue management and providing continuous support of inspection readiness.
A day in the life may look like:
Subject Matter Authority (SME) and key liaison to GDQ to provide support and advise on any issues to ensure compliance and for the Quality Risk Assessment process. Ensuring and responsible for initiatives and process improvements, in partnership with other functional areas. Responsible for the management of GCP-compliant activities from a quality perspective in conjunction with the business and the GDQM (GCP) team. Providing day-to-day quality and compliance support to cross-functional collaborators. Including issue management (triage/investigation/actions), audit responses, proactive quality management, Corrective Action/Preventive Action (CAPA) oversightThis may be the right role for you if you have experience:
Leading Quality Risk Management activities on clinical trials within assigned studies and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICH E6 R2. Partnering with Clinical Study Lead/Oversight Monitoring and CRO to provide oversight to site level quality risks. Working together with other GDQM (GCP) QMLs in relation to effective management of study specific issues. Responsible for owning the critical issue, to Executive Quality Leadership, for significant quality events and quality trends relative to studies, programs, and therapeutic areas. Advising on the escalation of any quality issues that potentially represent serious non-compliances (or serious breach)In order to be considered for this role, we are looking for candidates who have:
Bachelor's degree or equivalent experience with a minimum of 8 years of relevant healthcare/pharmaceutical proven experience in either a quality/compliance role or in a Clinical Development role. Strong Expertise with transferable skills related to Good Clinical Practice(GCP), and/or Good Pharmacovigilance Practice (GVP).
