Regional Lead Aseptic Excellence (Pharma), Boxmeer

Job Description

Shape the future of sterile manufacturing by combining science, technology, and leadership. We are recruiting a Regional Lead Aseptic Excellence (Pharma) who can be based in Boxmeer (NL), Unterschleissheim (D), Krems (A), Salamanca (E), Igoville, Vitré, Beaucouzé (F) or Dublin (IE). Role Overview

Reporting to the Global APS Lead, this role drives excellence, innovation, and continuous improvement across aseptic operations in Europe and the Asia Pacific. The Regional Lead will provide strategic microbiology and aseptic leadership to the regional APS team, guide improvements across the sterile manufacturing network, and support capital engineering projects to ensure new and existing assets meet the highest technical and compliance expectations.Key Responsibilities

Lead, coach and develop the regional APS team, building technical, microbiological and leadership capability. Contribute to the deployment of the APS and S&T Excellence strategy across Europe and the Asia Pacific region. Define, implement and continuously improve aseptic practices, policies and procedures in partnership with Operations, Engineering, Quality, Research and Development and other S&T functions. Drive operational excellence through process optimization, automation, best practice deployment, and right‑first‑time technology transfer and asset introduction. Provide expert microbiology and contamination control support to sterile and non‑sterile sites across the internal and external network.Lead investigations and root cause analyses for contamination deviations and ensure effective corrective and preventive actions. Serve as the Global Owner of Animal Health Sterile Standards, leading a global team of aseptic and microbiology experts to set strategy, maintain AHQM content, and ensure consistent implementation through governance, training and communities of practice.Develop and maintain systems, processes and metrics to monitor aseptic performance, including a network aseptic risk heatmap. Ensure alignment with global and local regulatory requirements and translate new expectations into practical guidance for the network. Build strong cross‑functional and cross‑regional relationships, including close partnership with Human Health colleagues to share learnings and align best practices.Qualifications

Bachelor’s or Master’s degree in Pharmaceutical Sciences, Biotechnology, Process Engineering, Microbiology, or a related discipline. Extensive industry experience in sterile manufacturing, with a proven track record of increasing responsibility and leadership. Strong understanding of aseptic manufacturing principles and biologics/sterile processes (e.g. cell culture, fermentation, or sterile drug product manufacturing).Strong leadership capabilities, with the ability to inspire, develop, and align diverse teams across regions and functions. Demonstrated success in stakeholder management, building trusted partnerships and influencing effectively across organizational levels. Solid experience with regulatory expectations and compliance in a highly regulated environment, including exposure to FDA, USDA, EMA Annex 1, and other relevant international guidelines.Proven ability to lead sites through successful regulatory inspections and other critical compliance activities. Strong change management skills, with experience driving transformation, implementing improvements, and guiding teams through change. Strategic thinker with excellent communication and collaboration skills, and the ability to thrive in a complex, fast‑paced environment.Innovative mindset with the ability to challenge the status quo and lead continuous improvement. Willingness to travel approximately 20% of the time and living within reasonable distance of the mentioned AH locations. Required Skills

Aseptic Manufacturing Change Leadership Contamination Control Contamination Investigation Driving Continuous Improvement High Performance Team Building Innovation Leadership Manufacturing Processes Manufacturing Quality Control Sterilization Team Management Preferred Skills

Strategic Thinker Excellent Communicator Experience in Multi‑Regulatory Environments Proficiency in Data‑Driven Risk Management Leadership in Continuous Improvement Initiatives

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