Associate Director GCP Quality

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The Regeneron Associate Director, GVP Quality Management Lead (QML) is a key position that will drive quality in Global Development by providing expert-level guidance and leadership for all aspects of quality and compliance within the Regeneron global pharmacovigilance (PV) system.

The Associate Director will utilize advanced interpersonal and communication skills, to work on diverse, complex matters. This involves analysis of issues, data, processes, and situations and requires advanced knowledge of pharmacovigilance and issue management.

This individual will create strategic partnerships and direct risk-based quality management activities with key stakeholders impacting the global Regeneron PV system. This will involve making independent decisions when implementing new projects and supporting technical/operational processes which are reported to executive level management.  Furthermore, the GVP Quality Lead will be responsible for supporting inspection readiness at all times. This role will partner with other members of the Global Development (GD) Quality department to lead the identification of trends through metrics in order to diagnose and remediate systemic quality issues.

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

• Responsible for identifying and initiating GVP-compliant activities from a quality perspective in conjunction with business and Director, GVP QML
• Lead relationship development 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.
• Lead/initiate process improvement activities and projects to drive quality objectives
• Act as a primary liaison to GPS to advise on any quality issues and ensure compliance
• Regularly partner with and influence cross-functional stakeholders regarding quality and compliance activities, including 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
• Deputize for Head, GVP QML
• Optimize 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
• Facilitate inspection response development with cross-functional stakeholders and process owners and management CAPA follow-up activities
• Deliver key messages in Quarterly Global Development Quality Oversight Committee and GPS Quality Council
• Review and contribute to multi-disciplinary meetings by sharing cross-functional skills and knowledge
• Guide and mentor team members at all levels and provide advice to senior management on complex/strategic issues.
• Other duties as required

    This role might be for you if:

• Bachelor’s degree (Master’s degree preferred) with 10 years of relevant industry experience
• 6 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.
• Makes independent decisions when implementing new projects and supporting technical/operational processes which report to executive level management.
• Identifies opportunities to initiate operational changes and policy modifications within PV and GD Quality.
• Influences project strategy, provides intellectual vision and guidance and is instrumental in driving the evolution of projects.
• Demonstrates exceptional initiative, creativity and innovation skills
• Applies expert-level understanding of pharmacovigilance and issue management with advanced interpersonal and communication skills
• Works on diverse, complex matters where analysis of issues, data, processes, and situations require advanced knowledge of PV.
• Regularly partners with and influences Directors, and/or other senior management within Global Development.
• 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.)
• 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
• Minimum of 10 years relevant 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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