Research Development Quality Inspection Management Lead (GCP/GVP)

Merck•Billerica, MA

7d•Hybrid

About The Position

An exciting new opportunity has arisen to join the company’s Global Inspection Management team as Inspection Management Lead. We are looking for a highly motivated individual with the ability to coordinate cross-functional and multicultural global teams. In this role you coordinate the preparation, execution and close out of GCP/ GVP Regulatory Authority Inspections of EMD Serono R&D projects or facilities. Responsibilities include the coordination of inspection setup activities and preparation of responses to inspection observations. You will also host or participate in inspections as a member of the Inspection Team. You will also work on projects to continuously improve the inspection management processes and educate internal and external business partners on inspection management processes.

Requirements

Minimum 8 years QA experience or other relevant experience with a minimum of 5 years in Clinical QA.
Bachelor’s degree with a focus on scientific subjects
Sound experience with Regulatory Authorities inspections by major authorities (MHRA, FDA, EMA, PMDA)
In depth knowledge of drug development processes and respective international regulations/guidelines
Broad knowledge of relevant GxP areas (GCP, GLP, GVP)

Nice To Haves

Advanced Degree Preferred
Good communication and problem- solving capabilities.
Demonstrated ability to work independently and manage time efficiently

Responsibilities

Coordinates the preparation, execution and close out all GCP/GVP Health Authority Inspections of R&D organization (hereafter referred to as Healthcare R&D) projects or facilities.
Hosts inspections and/or participates in inspections by providing full operational support to the respective inspection leads (Front Room, Back Room, etc.).
Develops and oversees implementation and maintenance of proactive Inspection Readiness Strategies.
Maintains an effective and controlled inspection process within Healthcare R&D worldwide (e.g. global inspection standard etc.).
Establishes an effective and controlled inspection communication process within Healthcare R&D worldwide.
Drives active and regular knowledge sharing and lessons learned from previous inspections.
Provides regular and timely reports on overall inspection status, global response status and associated CAPA completion/close out, allowing for and contributing to state-of-the-art Quality Reporting.
Enforces the continuous evaluation of publicly available inspection reports/ information from various sources to proactively develop and maintain an up-to-date Inspection Intelligence, identifying potential new or upcoming issues of significance and to foresee/ confirm new inspection trends or expectations.
Develops and maintains standardized and harmonized tools for the preparation, conduct, reporting and follow-up of inspections.
Assists in developing the global quality strategy and implementing/ maintaining the associated Quality Management System.
Participates in special assignments on various project teams and work streams as determined by RDQRM Management.
Maintains high level of awareness, expertise in international applicable regulations and provides input to the development of internal R&D procedures as assigned by RDQRM Management.
Ensures rapid communication of QA issues, including potential misconduct or issues of significant deviations with projects/products, to appropriate leaders and colleagues.
Defines the joint processes for collaboration on inspection preparation, notification, conduct, response with external providers.
Coordinates mock inspections in line with established processes for inspection management process.