Research Development Quality Inspection Management Lead; GCP​/GVP

Your Role

Inspection Management Lead in the Global Inspection Management team. This highly motivated individual will coordinate cross‑functional and multicultural global teams, oversee the preparation, execution, and close‑out of GCP/GVP Regulatory Authority Inspections of EMD Serono R&D projects or facilities, and manage responses to inspection observations. The role includes hosting or participating in inspections as a member of the inspection team.

Additionally, the Lead will work on projects to continuously improve inspection‑management processes and educate internal and external partners on those processes.

Location:

Hybrid (3x/week) based in Billerica, MA or Boston, MA, with onsite presence required at short notice to host inspections at both locations.

• Coordinate the preparation, execution and close‑out of all GCP/GVP Health Authority Inspections of R&D projects or facilities.
• Host inspections and/or provide operational support to inspection leads (Front Room, Back Room, etc.).
• Develop and oversee implementation of proactive inspection readiness strategies.
• Maintain an effective and controlled inspection process within Healthcare R&D worldwide.
• Establish an effective and controlled inspection communication process worldwide.
• Drive active knowledge sharing and lessons learned from previous inspections.
• Provide regular and timely reports on overall inspection status, global response status and CAPA completion, contributing to state‑of‑the‑art quality reporting.
• Continuously evaluate publicly available inspection reports to develop and maintain up‑to‑date inspection intelligence and identify emerging issues or trends.
• Develop and maintain standardized and harmonized tools for inspection preparation, conduct, reporting and follow‑up.
• Assist in developing the global quality strategy and implementing/maintaining the associated quality management system.
• Participate in special assignments on various project teams and work streams as directed by RDQRM Management.
• Maintain expertise in international regulations and input into the development of R&D procedures as required.
• Ensure rapid communication of QA issues, including potential misconduct or significant deviations, to appropriate leaders and colleagues.
• Define joint processes for collaboration on inspection preparation, notification, conduct and response with external providers.
• Coordinate mock inspections in line with established inspection‑management processes.

• Minimum 8 years of QA experience or equivalent, with at least 5 years in Clinical QA.
• Bachelor’s degree focused on scientific subjects.
• Sound experience with regulatory authority inspections by major agencies (MHRA, FDA, EMA, PMDA).
• In‑depth knowledge of drug development processes and relevant international regulations/guidelines.
• Broad knowledge of GxP areas (GCP, GLP, GVP).
• Travel globally up to 20%.

• Advanced degree preferred.
• Good communication and problem‑solving capabilities.
• Demonstrated ability to work independently and manage time efficiently.

Pay Range for this position: $139,400 – $209,200.

Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prerequisites.

We are committed to creating access and opportunities for all to develop and grow at your own pace.