The Regeneron Senior Manager, Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide guidance and leadership for all aspects of quality and compliance within Global Development Quality (GDQ) systems. The Sr. Manager will engage with key partners, build strategic partnerships working and liaising with study teams, relevant functions and other GDQ functions to lead risk-based quality management activities on all Regeneron-sponsored clinical trials, inclusive of issue management and providing continuous support of inspection readiness. The QML will partner with other colleagues to review trends through metrics in order to support diagnosis and remediation of systemic quality issues. The Senior Manager, GDQM (GCP) may also be assigned to line manage, coach and/or mentor more junior members of the team.
In this role, a typical day might include the following:
- Perform 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.
- Ensuring 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.
- 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) oversight, audit/issue trending.
- Engaging with, supporting, and collaborating closely with multiple cross-functional team members whose work impacts the GDQ system.
This role may be for you if:
- You bring skills in taking initiative and working independently across multiple areas.
- You can make decisions on complex issues under minimal guidance that have a significant impact on clinical trials.
- You Are self-motivated with the ability to work effectively and provide mentorship to others in a dynamic environment with ambiguity.
- You demonstrate a broad, experienced knowledge of clinical trial research, with an understanding of GCP for the development of pragmatic solutions.
- As a GCP authority, you will evaluate novel problems and develop novel solutions for critical organization-wide issues.
To be considered, we are looking for individuals with a Bachelors’ degree (Master’s degree preferred) or equivalent qualification with 8+ years of relevant industry experience. 5+ years proven experience working in either a compliance group, audit/QA, Quality Management/Quality Risk Management function, or university/hospital-based department with established experience and/or transferrable skills with Good Clinical Practices and Regulatory Inspections.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)