TEMP- Sr. Manager, GCP Quality Management Lead

Location
Tarrytown, NY, United States
Posted
Aug 24, 2019
Ref
17441BR
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Contract
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

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 create strategic partnerships and direct risk-based quality management activities with Clinical Study Teams. Furthermore, the GCP Quality Management Lead will be responsible for assuring that the Clinical Study Team and all relevant documents are inspection ready at all times. The GCP Quality Management Lead 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 requiredments are met ( including but not limited to executed study plans and "live" systems (EDC, TMF, etc.)

Responsibilities:

• Responsible for overseeing a program from a quality perspective within a therapeutic area in conjunction with business and supported by Manager and/or Sr Manager QMLs

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

• 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 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, including SSN/issue management (triage/investigation/actions), audit responses, proactive quality management, CAPA oversight, protocol deviation review, audit/protocol deviation/issue trending

• Interface 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

• Integral member of the Quarterly Quality Metrics Review as part of team with metrics/analytics and functional owners

• Monitor 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"

• Other duties as required

Requirements:

• Bachelor's degree ( Master's degree preferred) with 10+ years of relevant industry experience

• 6+ 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.

• 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 dynamic environment with ambuiguity

• Strong leadership with demonstrated ability to interface with senior leaders

• Good problem solving, written and verbal communication skills

• Ability to effectively manage 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

Core Behavioral Competencies:

• Leadership

• Executive Presence

• Stakeholder Management

• Project Management

• Process Management

• Strategic Thinking

• Critical Thinking & Problem Solving

• Integrity and Trust

• Negotiating

• Organizational & Political Savvy

• Dealing with ambiguity & paradox

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.