Temp- Senior Manager, Quality Management Lead
Regeneron Pharmaceuticals Inc

Job Info

The Regeneron GCP Quality Management Lead (QML) is a key position that will provide guidance and leadership for preparation and conduct of Regeneron-sponsored clinical trials from the time of synopsis generation and protocol authoring through final CSR. This individual will build strategic partnerships and direct risk-based quality management activities with Clinical Study Teams. We expect you will be responsible for assuring that the Clinical Study Team and all relevant documents are inspection ready at all times. The QML will partner with other members of the GCP Quality department to identify trends through metrics in order to diagnose and remediate systemic quality issues. S/he will also have responsibility for ensuring that no study "goes live" until all basic requirements are met (including but not limited to executed study plans and "live" systems (EDC, TMF, etc.)
In this role, a typical day might include the following:

Responsible for leading all aspects of 2-4 studies from a quality perspective within a program in conjunction with business and Associate Director/Director, QML

Lead Quality Risk Management activities on all Regeneron-sponsored clinical trials within assigned studies

Lead Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICH E6 R2

Reassess quality risks throughout the study and adjust the plan as necessary

Partner with Regeneron Clinical Study Lead/Oversight Monitoring/CRO to supervise site level quality risks

Participate as an active Clinical Study Team (CST) member

Provide day to day quality and compliance support to CST members, including SSN/issue management (investigation/actions), audit responses, proactive quality management, CAPA oversight, protocol deviation review, audit/protocol deviation/issue trending

Collaborate with Associate Director and Director, GCP Quality Management Lead, to roll-up study information and trends

Collaborate with GCP Quality Inspection Management Team to assure that studies within assigned program are inspection ready at all times, including conduct of quality assessments, participation in site inspection readiness visits, and participation in inspection conduct

Perform periodic TMF reviews to assist teams in achieving a real-time approach to inspection readiness

Participate in Quarterly Quality Metrics Review

Track the study "Green Light" process assuring that no patient is entered into any clinical trial until all study level plans are approved and EDC, IxRS and ePRO have "gone live"
This role might be for you if:

We desire a Bachelor's degree (Master's degree preferred) with 8+ years of relevant industry experience

We look for 5+ years' experience working in either a clinical compliance group, QA Quality Management/Quality Risk Management function, or Clinical Development with expertise and/or transferrable skills with Good Clinical Practice and Regulatory Inspections.

Excellent communication skills and ability to work with people in all levels of the organization and externally.

Proven skills in taking initiative and working independently

Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.

Proven experience in driving Quality into the Clinical Trial Operations processes

Self-motivated with the ability to work effectively in a dynamic environment with ambiguity

Strong leadership with demonstrated ability to work with senior leaders

Good problem solving, written and verbal communication skills

Ability to effectively lead multiple priorities

Consistent track record of project management, partner management, teamwork skills and resolving complex situations

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.