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Associate Director Inspection Management (GCP)
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Associate Director, Global Development Quality Inspection Management (GDQIM)
Acting as an Inspection Management Lead (IML), this key position is responsible for the effective management of GCP, GVP, and GLP inspections. The GDQIM IML will engage with key stakeholders, build strategic partnerships, and work with Clinical Study teams, relevant functions, and other GDQ functions to support inspection preparation activities on all Regeneron-sponsored clinical trials.
Typical Day Responsibilities
- Ensuring and managing the notification of all relevant internal and external stakeholders of upcoming and/or anticipated regulatory inspections.
- Ensuring the preparation, management, and integration of inspection management processes and training activities into clinical development programs and all relevant stakeholders.
- Providing effective guidance, consultancy, and support to Clinical Study Teams and other key stakeholders in advance of an impending inspection.
- Assisting with the identification of opportunities to conduct mock inspections and/or Investigator Site Preparation Visits in collaboration with the GD Quality Assurance (GDQA) team and other relevant functional groups.
- Identifying and discussing with Clinical Study Teams potential issues and/or gaps, in advance of an impending inspection, that may require strategies to mitigate risk and/or provide additional clarification to an inspector.
- Ensuring the preparation, management, and conduct of inspection preparation sessions which include mock inspections, trainings, and clinical site preparation visits working with GDQA team to identify and mitigate risks to clinical programs.
- Serving as the back room lead/co-lead or front room co-lead, responsible for explaining, managing, and ensuring the execution of all activities, including managing the tracking of requests and inquiries, and coordinating requests for responses from relevant personnel during any regulatory inspection conducted worldwide.
- Responsible for managing the preparation and provision of timely inspection updates and daily/end of inspection summaries to GD Executive and Senior Management, in addition to any other key relevant internal and external stakeholders.
- Responsible for managing inspection response development, and Corrective Actions/Preventive Actions (CAPA) follow-up activities alongside other GDQIM colleagues, cross-functional stakeholders, and process owners.
- Ensuring and managing the development, collection, reporting, and analysis of inspection-related quality data, trends, and metrics.
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Qualifications
This Role May Be For You If You Have
- Advanced knowledge, understanding, and application of GCP and/or GVP guidelines including the management of significant/complex quality issues and compliance activities.
- Extensive experience with participating in, and supporting, Regulatory Agency Inspections of Investigator Sites, Sponsors, and Clinical Research Organizations (CROs) in a GxP environment, including inspection preparation, facilitation, and follow-up.
- Effective management of interpersonal relationships, stakeholder engagement, and collaborations.
- Demonstrated ability to interface and collaborate effectively with other Managers and Directors within, and external to, the organization.
- Extensive experience in providing training and presenting information on key quality and regulatory compliance information.
Required Experience
To be considered for this opportunity we are looking for:
- Bachelor's degree with a minimum of 10 years of relevant healthcare/pharmaceutical industry experience.
- Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance, etc.), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP) and/or Good Pharmacovigilance Practice (GVP).
- Experience in training, supervising, line management, mentoring, and development of staff, and leading a small team.
About Us
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
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Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Onsite Expectations
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
Background Checks
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work, and educational qualifications.
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