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 all Regeneron-sponsored clinical trials.
Responsibilities
Ensure and manage notifications of all relevant internal and external stakeholders of upcoming and/or anticipated regulatory inspections.
Ensure the preparation, management, and integration of inspection management processes and training activities into the clinical development programs.
Provide effective guidance, consultancy, and support to the Clinical Study Teams and other key stakeholders in advance of an impending inspection.
Assist 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 functional groups.
Identify and discuss with the Clinical Study Teams potential issues and gaps that may require strategies to mitigate risk and/or provide additional clarification to an inspector.
Ensure the preparation, management, and conduct of inspection preparation sessions including mock inspections, trainings, and clinical site preparation visits, working with GDQA team to mitigate risks.
Serve as the back room lead/co-lead or front room co-lead, responsible for explaining, managing, and ensuring the execution of all activities.
Manage preparation and provision of timely inspection updates and daily/end of inspection summaries to GD Executive and Senior Management and other stakeholders.
Manage inspection response development, CAPA follow-up activities with cross-functional stakeholders and process owners.
Ensure and manage 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 management of significant or complex quality issues and compliance activities.
Extensive experience participating in, and supporting, regulatory agency inspections of investigator sites, sponsors, and clinical research organizations in a GxP environment.
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
Bachelor's degree with a minimum of 10 years of relevant healthcare/pharmaceutical industry experience.
Experience working in a quality/compliance role (e.g., Quality Management, Quality Assurance) or in a Clinical Development role with expertise and/or transferable skills related to GCP and/or GVP.
Experience in training, supervising, line management, mentoring, and development of staff, and leading a small team.
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 Travel 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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