Research Development Quality Inspection Management Lead (GCP/GVP)

Inspection Management Lead

Work Your Magic with us! Start your next chapter and join EMD Electronics.

Ready to explore, break barriers, and discover more? We know you've got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Everything we do in EMD Electronics is to help us deliver on our purpose of being the company behind the companies, advancing digital living. We are dedicated to being the trusted supplier of high-tech materials, services and specialty chemicals for the electronics, automotive and cosmetics industries. We foster a global collaborative organization made up of individuals who have the passion to win, obsess about the customer, are relentlessly curious and act with urgency. Together, we push the boundaries of science to make more possible for our customers.

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.

This is a hybrid (3x/week) position based in Billerica, MA or Boston, MA. Onsite presence will be required at short notice to host inspections at both locations.

Key Accountabilities:

• 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.

Who You Are:

Minimum Qualifications:

• 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)
• Travel globally up to 20%

Preferred Qualifications:

• 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 The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prequisites.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!