Senior Manager, Quality Management- Global Development

Overview

The 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 GDQM (GCP) QML will engage with key stakeholders, 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.

For US locations (Armonk, NY or Warren, NJ), this role is on-site 4 days in the office and 1 day from home. For Uxbridge, UK or Dublin, Ireland this role would be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position.

• Acting 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 stakeholders, including issue management (triage/investigation/actions), audit responses, proactive quality management, CAPA oversight, audit/issue trending.
• Engaging with, supporting, and liaising with multiple cross-functional stakeholders whose work impacts the GDQ system.
• Leading Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICHGCP.

• 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).
• Providing consultation, mentorship, training, and support in respect to compliance with applicable international regulations, practices, and guidelines.
• Advising on the escalation of any quality issues that potentially represent serious non-compliances (or serious breach) via the issue escalation process.
• Supporting the collection and reporting of data (e.g., metrics).
• Contributing to and supporting process improvement initiatives and work groups, as assigned.
• Exemplifying a quality mindset and behaviors in all interactions with internal and external colleagues, serving as an ambassador for GDQ.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!

For additional information about Regeneron benefits in the US, please visit  For other countries’ specific benefits, please speak to your recruiter.

Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

Salary Range (annually)

$ - $