Specialist Quality

Job Description For our Animal Health location Boxmeer, we are currently recruiting a
** Specialist Quality
**** 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, which includes a powder filling line, in Boxmeer to bring our latest animal health innovations to market. Once the manufacturing facility is fully operational (expected in 2030), it will create about 80–100 FTE jobs.

The facility will include dedicated warehouse, manufacturing, quality assurance, quality control, 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 Specialist Quality.
** Purpose of the role
** In this role, you help build and maintain the Quality System foundation for a new EU/FDA‑compliant manufacturing facility. Throughout construction, commissioning, and the transition to commercial operations, you implement, operationalize, and improve site Quality Systems to ensure full cGMP readiness. This includes translating global standards and regulatory requirements into practical, site‑specific processes that enable safe and compliant manufacturing. As a subject matter expert, you provide system oversight, technical guidance and hands‑on support to project teams and site functions.

You ensure systems are robust, inspection‑ready, and aligned with the 7 attributes of a strong QMS, while also contributing to global harmonization through cross‑site collaboration. Success requires a proactive, analytical, and solution‑oriented mindset. You balance regulatory expectations with practical implementation, support audits and regulatory inspections, promote continuous improvement and Lean behaviors, and coach colleagues to strengthen quality culture. Your work ensures a future‑proof QMS and prepares the facility to deliver safe, high‑quality products at start‑up and beyond.
** Key tasks and responsibilities
*** Own and continuously improve assigned Quality Systems to ensure cGMP‑compliant, robust performance.
* Translate GMP requirements into practical site procedures and tools to support readiness.
* Oversee Investigations & CAPA, ensuring timely and compliant closure.
* Provide system and compliance expertise for investment projects and validated status.
* Review qualification documentation for equipment, software, and facilities.
* Lead internal audits for assigned systems and monitor CAPA progress.
* Support supplier management activities, including audits and TQAs.
* Prepare for and support regulatory inspections and implement system updates.
* Maintain key site quality documents (e.g., SMF, VMP, CCS, Compliance Plan).
* Lead change management and documentation processes for assigned systems.
* Act as point of contact for inter‑site quality agreements and coordination.
* Promote safety and help integrate QMS, Lean, and continuous improvement behaviors.
* Coach colleagues and contribute to quality strategy through system performance insights.
** Your profile
*** Degree-qualified in a relevant scientific discipline (BSc or MSc in Pharmacy, Medical Biology, Chemistry, Process Technology or similar)
* A minimum of 10 years’ broad Quality (Systems) experience, EU and FDA, in an international pharmaceutical/animal‑health environment, preferably experience within a production facility.
* 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…