Senior Manager, Quality Management Lead, GCP Quality

Location
Tarrytown, NY, United States
Posted
Oct 12, 2020
Ref
21762BR
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
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.
In this role, a typical day might include the following:

We expect you to be 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.

We expect you to partner with Regeneron Clinical Study Lead/Oversight Monitoring/CRO to monitor site level quality risks.

Participate as an active Clinical Study Team (CST) member.

Provide day to day quality and compliance support to CST members. This includes 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.

Work with GCP Qualty 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.

Supervise 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 seek a Bachelor's degree (Master's degree preferred) with 8+ years of relevant proven 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 interpersonal skills and ability to work with people in all levels of the organization and externally.
  • Demonstrated skills in taking initiative and working independently
  • Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.
  • Demonstrated experience in driving Quality into the Clinical Trial Operations processes
  • Self-motivated with the ability to work effectively in a multifaceted environment with ambiguity
  • Strong leadership with proven ability to work with senior leaders
  • Good problem solving, written and verbal communication skills
  • Ability to effectively lead multiple priorities with a sense of urgency
  • Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations
  • Attention to detail and accuracy of work
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.