Regeneron Pharmaceuticals Senior Manager, Quality Management Lead in Tarrytown, New York
The Regeneron GVP Quality Management Lead (QML) is a key position that will provide guidance and leadership for all aspects of quality and compliance within the Regeneren global pharmacovigilance (PV) system. This individual will create strategic partnerships and direct risk-based quality management activities with key stakeholders impacting the global Regeneron PV system. Furthermore, the GVP Quality Lead will be responsible for supporting inspection readiness at all times. The GVP Quality Lead will partner with other members of the Global Development (GD) Quality department to identify trends through metrics in order to diagnose and remediate systemic quality issues.
In this role, a typical day might include the following:
Responsible for leading GVP-compliant activities from a quality perspective in conjunction with business and Director, GVP QML
Engage with, support and liaise with multiple cross-functional stakeholders whose work impacts the Regeneron global PV system, including but not limited to: Global Patient Safety (GPS), Medical Affairs, Regulatory, Commercial, etc
Participate in process improvement activities and lead projects in support of quality objectives
Act as a primary liaison to GPS to advise on any quality issues and ensure compliance
Provide day-to-day quality and compliance support to cross-functional stakeholders, including Suspected Serious Non-compliance (SSN)/issue management (triage/investigation/actions), audit responses, proactive quality management, CAPA oversight, audit/issue trending
Interface with other QMLs within GD Quality in relation to study-specific issues, including PASS
Interface with Director, GVP QML, to roll-up pertinent information and trends
Lead assigned inspection readiness activities in alignment with GD Quality Inspection Management Team to assure key functional areas are inspection ready at all times, and participation in inspection conduct
Faciliatate inspection response development with cross-funcational stakeholders and process owners and management CAPA follow-up activities
Participate in Quarterly Quality Metrics Review
This role might be for you if:
5+ years’ experience working in either a PV compliance group, PV audit/QA, Quality Management/Quality Risk Management function, or PV department with expertise and/or transferrable skills with Good Pharmacovigilance Practices and Regulatory Inspections.
Regularly makes decisions under minimal guidance that have a significant impact on the organizations business operations
Advises one or more areas, programs, or functions and provides recommendations to senior executives on matters of significance
Works with senior management, consults on solution development for novel or strategic business and technical issues with significant impact on organization-wide compliance and efficiency with far-reaching impact
Works cross-functionally throughout the organization and is a sought out resource for pharmacovigilance expertise
Serves as a strategic advisor to senior management and drives appropriate actions, while ensuring implementation of compliance solutions
Independently determines methods and procedures on new assignments and often coordinates activities/provides technical guidance to others
Operates in ambiguous situations and provides process/technical/functional guidance to others
As a PV expert, with a strong understanding of GCP, uses professional concepts to evaluate novel problems and develop novel solutions for critical organization-wide issues
Experience in managing quality and compliance issues related to clinical trial safety (e.g. SUSAR reporting, DSURs, RSI, etc)
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
Bachelor’s degree (Master’s degree preferred) with 8+ years of relevant industry experience
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.
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