Associate Director Inspection Management (GCP) in Uxbridge

The Associate Director, Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is a key position that is responsible for the effective management of GCP, GVP and GLP inspections. The GDQIM IML will engage with key stakeholders, build strategic partnerships working and liaising with Clinical Study teams, relevant functions and other GDQ functions to support teams with inspection preparation activities on Regeneron-sponsored clinical trials.

Responsibilities

• Managing the notification of all relevant internal and external stakeholders of upcoming and/or anticipated regulatory inspections.
• Preparing, managing and integrating inspection management processes and training activities into the clinical development programs and all relevant stakeholders.
• Providing effective guidance, consultancy, and support to the 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 the 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 including mock inspections, trainings, and clinical site preparation visits in collaboration with the 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.
• Managing the preparation and provision of timely inspection updates and daily/end of inspection summaries to GD Executive and Senior Management, in addition to other key relevant internal and external stakeholders.
• 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.

Qualifications

• 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.

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) 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.

Additional information

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, sexual orientation, disability, genetic information, familial status, pregnancy or parental status, gender identity, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Background checks will form part of the recruitment process and will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose is to verify information prior to the commencement of employment such as identity and education credentials.