Quality Systems & Compliance Project Lead

Overview

New, highly independent, hands-on project role with significant operational and strategic responsibilities. For our Animal Health location Boxmeer, we are recruiting a Quality Systems & Compliance Project Lead. Welcome to our team Our production facilities in Boxmeer are part of our global animal health production network and manufacture and package animal health products according to Good Manufacturing Practice standards (GMP). Currently, we are investing in a new EU- and FDA-compliant manufacturing facility and powder filling line in Boxmeer to bring our latest animal health innovations to market. Once the plant is fully operational, it will create about 80–100 FTE jobs. The facility will include dedicated warehouse, manufacturing, quality, and packaging & labeling teams to deliver high-quality, compliant products. To accelerate delivery of robust, compliant and future-proof Quality Systems that will enable safe and compliant product manufacture, we are looking for a Quality Systems & Compliance Project Lead. Purpose of the role Reporting to the Project Quality Lead, you will lead Quality Systems ownership and provide subject‑matter expertise to establish robust QMS for the new plant during construction and commissioning. You will implement and maintain Quality Systems in line with our Animal Health Quality Manual (AHQM), EU/FDA legislation and our organization’s global guidance, drive system improvements, and provide plant-level oversight to ensure cGMP readiness during the project-to-commercial transition. You initiate system development, translate global requirements into practical site solutions, and create clear insight into the plant’s quality status. You will act as a key compliance resource during regulatory interactions and inspections, provide system-level support for investment projects, and embed continuous improvement and Lean behaviors. What we offer The opportunity to step into a new, hands-on position where you’ll work independently, collaborate across functions and take on real leadership responsibilities. Our benefits are very competitive, and the summary below will give you an idea of what you can expect. Competitive salary and a 3% year-end allowance. 35,5 days of leave. Attractive collective health care insurance package with considerable reduction rates. Solid Pension Plan. Annual bonus based on own and company performance. Travel allowance for commuting. Numerous training, coaching and e-learning modules for long term job opportunities and development. Key tasks and responsibilities Own, maintain and continuously improve assigned Quality Systems at system level, ensuring robustness, effectiveness and efficiency in line with the 7 attributes of a robust Quality System, global guidelines and applicable legislation. Translate theoretical GMP requirements into pragmatic, site-specific procedures and tools and lead implementation to support cGMP readiness. Provide system oversight for Change Control, Deviation Investigation & CAPA, including tracking and ensuring timely completion of corrective and preventive actions on system and content levels. Act as System & Compliance expert and coordinator for major investment projects; ensure project activities meet QMS and regulatory expectations. Lead and maintain the internal audit program for assigned Quality Systems; execute audits and monitor audit CAPA progress. Manage supplier management system elements (supplier audits, Technical Quality Agreements, supplier assessments) and related IT systems where applicable. Prepare for, coordinate and lead responses during regulatory inspections and inquiries related to your systems; defend systems to inspectors and implement required system/SOP changes. Maintain and update Site Master File, Validation Master Plan, Contamination Control Strategy and Compliance Plan as relevant to assigned systems. Serve as central point of contact for inter-site relations and site-to-site Technical Quality Agreements where relevant. Promote safety culture and drive the integration of QMS, MPS and Inclusion using Lean and Quality & Compliance tools (e.g., PIR, Tier structure, Ho-Shin Kan-ri, Go-Sees). Provide coaching and knowledge transfer to colleagues, act as a resource for less experienced team members. Measure and report system performance and improvement metrics; proactively contribute to local quality strategy and site objectives. Your profile Degree-qualified in a relevant scientific discipline (BSc or MSc in Pharmacy, Medical Biology, Chemistry, Process Technology or similar). Strong, broad quality systems experience in international pharmaceutical and animal health environments, with working knowledge of EU and FDA regulatory expectations, Annex 1 requirements, contamination control strategies, and cleanroom classification. Proven track record interacting with health authorities and/or managing audits and inspections. Detail‑oriented and risk‑aware, with strong systems thinking to translate global GMP requirements into practical site solutions and the drive to deliver project milestones on schedule. Excellent communicator who can engage diverse stakeholders, coach and develop colleagues, and champion continuous improvement and Lean practices while always prioritizing safety, product quality and regulatory compliance. Fluent in English and Dutch (or willing and able to learn Dutch quickly). Based within a reasonable commuting distance of Boxmeer and available onsite at least three days per week. Application details Please send an email including the vacancy number and job title to the following address: RecruitmentNL@MSD.com. Applications can only be submitted through our career site. Requisition ID:

R367517 Important notices Search firm representatives: Merck & Co., Inc. does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted without a valid written agreement will be the sole property of the company.

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