Associate Director Inspection Management (GCP)

Regeneron; City Of London; On-site; GBP 80,000 - 120,000; Full time

Job summary

A leading biotechnology company in the City of London is seeking an Associate Director to lead the Global Development Quality Inspection Management. You will manage GCP and GVP inspections, foster stakeholder collaborations, and support Clinical Study teams in preparing for inspections. Ideal candidates will have a Bachelor's degree and at least 10 years of experience in the healthcare or pharmaceutical field, particularly in quality and compliance roles. Competitive compensation is offered.

Qualifications

• Minimum of 10 years of experience in healthcare/pharmaceutical industry.
• Experience in a quality/compliance role or Clinical Development role.
• Experience in training and development of staff.

Responsibilities

• Engage with stakeholders for inspection preparation activities.
• Manage notifications for upcoming inspections.
• Conduct mock inspections and site preparation visits.
• Analyze and report inspection-related quality data.

Skills

Knowledge of GCP and GVP guidelines

Stakeholder management

Regulatory compliance training

Quality issue management

Education

Bachelor's degree

Job description

Overview

The Associate Director, Global Development Quality Inspection Management (GDQIM) acts as an Inspection Management Lead (IML) and is responsible for the effective management of GCP, GVP, and GLP inspections. The GDQIM IML engages with key stakeholders, builds strategic partnerships, and supports Clinical Study teams and other GDQ functions to prepare for inspections on all Regeneron-sponsored clinical trials.

Typical Day

• Ensure and manage the notification of all internal and external stakeholders of upcoming and/or anticipated regulatory inspections.
• Prepare, manage, and integrate inspection management processes and training activities into the clinical development programs and relevant stakeholders.
• Provide effective guidance, consultancy, and support to Clinical Study Teams in advance of an impending inspection.
• Assist with mock inspections and/or Investigator Site Preparation Visits in collaboration with the GDQA team and other functional groups.
• Identify and discuss potential issues or gaps with Clinical Study Teams that may require risk mitigation strategies or additional clarification to an inspector.
• Prepare, manage, and conduct 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, managing tracking of requests and inquiries, and coordinating responses during any regulatory inspection worldwide.
• Manage the preparation and provision of timely inspection updates and daily/end of inspection summaries to GD Executive and Senior Management.
• Manage inspection response development and CAPA follow-up activities alongside cross-functional stakeholders.
• Develop, collect, report, and analyze inspection-related quality data, trends, and metrics.

Responsibilities

• Engage with stakeholders and build strategic partnerships to support inspection preparation activities.
• Manage notification processes for upcoming inspections.
• Integrate inspection management processes into clinical development programs.
• Consult and support clinical teams prior to inspections.
• Coordinate mock inspections and site preparation visits.
• Identify risk mitigation strategies and provide clarifications to inspectors.
• Lead front room or back room inspection activities worldwide.
• Provide inspection updates and summaries to executive leadership.
• Follow up on CAPA and inspection response activities.
• Analyze and report inspection-related quality data and metrics.

Qualifications

• Advanced knowledge, understanding, and application of GCP and GVP guidelines, including management of significant or complex quality issues and compliance activities.
• Extensive experience supporting regulatory agency inspections of investigator sites, sponsors, and CROs in a GxP environment.
• Effective management of stakeholder relationships and collaboration.
• Demonstrated ability to interface and collaborate with managers and directors within and external to the organization.
• Experience in providing training and presenting quality and regulatory compliance information.

A Candidate

• Bachelor's degree with a minimum of 10 years of relevant healthcare/pharmaceutical industry experience.
• Experience in a quality/compliance role or a Clinical Development role with in GCP and/or GVP.
• Experience in training, supervising, and developing staff, and leading a small team.

EEO Statement

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, 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 provide reasonable accommodation for qualified applicants with disabilities unless it would impose undue hardship on the operation of the business.