Senior Manager, Global Development Quality Management (GCP)
Acting as a Quality Management Lead (QML), this key position provides guidance and leadership for all aspects of quality and compliance within Global Development Quality (GDQ) systems.
The GDQM (GCP) QML engages with key stakeholders, builds strategic partnerships, and works with study teams, relevant functions, and other GDQ functions to lead risk-based quality management activities on all Regeneron-sponsored clinical trials. This includes issue management and providing continuous support of inspection readiness.
This is a hybrid position with 3 days on-site requirement.
Key Responsibilities:
* Acts as a Subject Matter Expert (SME) and key liaison to GDQ to provide support and advise on any quality issues to ensure compliance and for the Quality Risk Assessment process.
* Ensures and responsible for Risk-Based Quality Management (RBQM) 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.
* Provides day-to-day quality and compliance support to cross-functional stakeholders, including issue management (triage/investigation/actions), audit responses, proactive quality management, Corrective Action/Preventive Action (CAPA) oversight, audit/issue trending.
* Engages with, supports, and liaises with multiple cross-functional stakeholders whose work impacts the GDQ system.
* Leads Quality Risk Management activities on all Regeneron-sponsored clinical trials within assigned studies.
* Leads Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICH E6 R2.
* Partners with Clinical Study Lead/Oversight Monitoring and CRO to monitor site level quality risks.
Requirements:
* Advanced knowledge, understanding and application of GCP, and/or GVP guidelines including the management of significant/complex quality issues and compliance activities.
* Advanced knowledge, understanding and application of proactive quality management, risk assessment/management, in addition to providing GCP consultancy and support to internal and external stakeholders.
* Experience serving as a subject matter expert/process owner/business process owner in a quality related field/area.
* Experience in providing training and presenting information on key quality and regulatory compliance information.
* Advanced knowledge and application of risk-based approaches to quality management and oversight, building fit-for-purpose quality processes in partnership with cross-functional teams and leaders.
Qualifications:
* Bachelor's degree with a minimum of 8 years of relevant healthcare/pharmaceutical industry experience.
* Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc.), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP).