Position Overview
The Associate Director, Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is responsible for effective management of GCP, GVP, and GLP inspections across all Regeneron-sponsored clinical trials. The IML engages with key stakeholders, builds strategic partnerships, and supports clinical study teams with inspection preparation activities.
Responsibilities
- Ensure notification of all relevant internal and external stakeholders of upcoming or anticipated regulatory inspections.
- Prepare, manage, and integrate inspection management processes and training activities into clinical development programs.
- Provide guidance, consultancy, and support to Clinical Study Teams in advance of inspections.
- Assist in identification and execution of mock inspections and Investigator Site Preparation Visits with GDQA and other functional groups.
- Identify and discuss potential issues or gaps with Clinical Study Teams to mitigate risk and provide clarification to inspectors.
- Conduct inspection preparation sessions, including mock inspections and training, working with GDQA to mitigate risks.
- Serve as back‑room or front‑room lead, managing execution, tracking requests and inquiries, and coordinating responses during regulatory inspections worldwide.
- Manage preparation and provision of timely inspection updates and summaries for GD Executive and Senior Management.
- Develop inspection responses and follow‑up CAPA activities with GDQIM colleagues and cross‑functional stakeholders.
- Develop, collect, report, and analyze inspection‑related quality data, trends, and metrics.
Qualifications
- Advanced knowledge, understanding, and application of GCP and/or GVP guidelines and management of significant/complex quality issues.
- Extensive experience supporting regulatory agency inspections of investigator sites, sponsors, and CROs in a GxP environment (preparation, facilitation, follow‑up).
- Effective interpersonal and stakeholder engagement skills.
- Ability to interface and collaborate with managers and directors internally and externally.
- Extensive experience delivering training and presenting quality and regulatory compliance information.
Required Experience
- Bachelor’s degree with a minimum of 10 years of relevant healthcare/pharmaceutical industry experience.
- Experience in a quality/compliance role (e.g., Quality Management, Quality Assurance) or in a Clinical Development role with GCP/GVP expertise.
- Experience in training, supervising, line management, mentoring, and leading a small team.
Equal Employment Opportunity Statement
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 parental status, gender identity, gender reassignment, military or veteran status, 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.
#J-18808-Ljbffr”, “datePosted”: “2026-05-19”, “hiringOrganization”: { “@type”: “Organization”, “name”: “BioSpace”, “sameAs”: “https://uk.whatjobs.com/pub_api__cpl__435989991__4861?utm_campaign=publisher&utm_medium=api&utm_source=4861&geoID=33” }, “jobLocation”: { “@type”: “Place”, “address”: { “@type”: “PostalAddress”, “addressLocality”: “London” } } }Position Overview
The Associate Director, Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is responsible for effective management of GCP, GVP, and GLP inspections across all Regeneron-sponsored clinical trials. The IML engages with key stakeholders, builds strategic partnerships, and supports clinical study teams with inspection preparation activities.
Responsibilities
- Ensure notification of all relevant internal and external stakeholders of upcoming or anticipated regulatory inspections.
- Prepare, manage, and integrate inspection management processes and training activities into clinical development programs.
- Provide guidance, consultancy, and support to Clinical Study Teams in advance of inspections.
- Assist in identification and execution of mock inspections and Investigator Site Preparation Visits with GDQA and other functional groups.
- Identify and discuss potential issues or gaps with Clinical Study Teams to mitigate risk and provide clarification to inspectors.
- Conduct inspection preparation sessions, including mock inspections and training, working with GDQA to mitigate risks.
- Serve as back‑room or front‑room lead, managing execution, tracking requests and inquiries, and coordinating responses during regulatory inspections worldwide.
- Manage preparation and provision of timely inspection updates and summaries for GD Executive and Senior Management.
- Develop inspection responses and follow‑up CAPA activities with GDQIM colleagues and cross‑functional stakeholders.
- Develop, collect, report, and analyze inspection‑related quality data, trends, and metrics.
Qualifications
- Advanced knowledge, understanding, and application of GCP and/or GVP guidelines and management of significant/complex quality issues.
- Extensive experience supporting regulatory agency inspections of investigator sites, sponsors, and CROs in a GxP environment (preparation, facilitation, follow‑up).
- Effective interpersonal and stakeholder engagement skills.
- Ability to interface and collaborate with managers and directors internally and externally.
- Extensive experience delivering training and presenting quality and regulatory compliance information.
Required Experience
- Bachelor’s degree with a minimum of 10 years of relevant healthcare/pharmaceutical industry experience.
- Experience in a quality/compliance role (e.g., Quality Management, Quality Assurance) or in a Clinical Development role with GCP/GVP expertise.
- Experience in training, supervising, line management, mentoring, and leading a small team.
Equal Employment Opportunity Statement
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 parental status, gender identity, gender reassignment, military or veteran status, 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.
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