GCP Quality Management Lead

The Regeneron Quality Management Lead (QML) is a key position that will provide guidance and leadership for all aspects of compliance and quality within the Regeneron global development quality systems. We feel this individual will engage with key partners impacting the global Regeneron GDQ systems. Furthermore, the Lead will provide continuous support of inspection readiness. The QML will partner with other members of the Global Development (GD) Quality department to review trends through metrics in order to support diagnosis and remediation of systemic quality issues.

In this role, a typical day might include the following:

• Responsible for leading GCP-compliant activities from a quality perspective in conjunction with business and the AD/Director, QML.
• Engage with, support, and liaise with multiple cross-functional partners whose work impacts the global development quality system.
• Provide day-to-day quality and compliance support to cross-functional collaborators, including Suspected Serious Non-compliance (SSN)/issue management (triage/investigation/actions), audit responses, proactive quality management, CAPA oversight, audit/issue trending.
• Act as a subject-matter expert and key liaison to GDQ to advise on any quality issues and ensure compliance.

This role may be for you if:

• Proven skills in taking initiative and working independently across multiple areas.
• Regularly makes decisions on complex issues under minimal guidance that have a significant impact on clinical trials.
• Self-motivated with the ability to work effectively and provide mentorship to others in a dynamic environment with ambiguity.
• Demonstrates a broad, experienced knowledge of clinical trial research, with an understanding of GCP for the development of pragmatic solutions.
• Advises one or more areas, programs, or functions and provides recommendations to senior management on matters of significance.
• As a GCP authority, with a strong understanding of GCP, 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 6+ years of relevant industry experience. 3+ 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.

#LI-Hybrid #GDRAJobs

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)

$108,200.00 - $176,600.00