Regional Lead Aseptic Excellence (Pharma)
MSD Malaysia
Regional Lead Aseptic Excellence (Pharma) page is loaded## Regional Lead Aseptic Excellence (Pharma)remote type: Hybridlocations: NLD - North Brabant - Boxmeer: AUT - Lower Austria - Krems An Der Donau: DEU - Bayern - Unterschleissheimtime type: Full timeposted on: Posted Todaytime left to apply: End Date: May 28, 2026 (20 days left to apply)job requisition id: R386479Job Description*Shape the Future of Sterile Manufacturing Through Science, Technology and Leadership*For our Animal Health organization, we are currently recruiting a **Regional Lead Aseptic Excellence (Pharma)**This position can be based in Boxmeer (NL), Unterschleissheim (D) or Krems (A).**Welcome to our team**Our Global Science and Technology division provides technical leadership to our Animal Health manufacturing network, using science, technology and innovation to enable successful new product launches and ensure reliable supply of our existing portfolio. Within this division, our global Aseptic Process Solutions team includes around 30 specialists across 9 countries and 4 continents. The team provides deep technical support to production and quality organization’s worldwide, ensuring robust processes and the consistent supply of our sterile products. Our mission is to lead Aseptic Excellence across our internal and external sterile network. We deliver this through fit for purpose standards, a zero sterile reject mindset, strong microbiology capability and a culture of continuous improvement. To strengthen our organization and to lead a regional team of 10 APS specialists, we are seeking a Regional Lead APS covering Europe and the Asia Pacific region.**Purpose of the role**Reporting to the Global APS Lead, this important new role drives excellence, innovation and continuous improvement across aseptic operations in Europe and the Asia Pacific region. You will provide strategic microbiology and aseptic leadership to the regional APS team and guide improvements across the sterile manufacturing network. You will initiate and lead a broad range of improvement projects that strengthen aseptic practice, contamination control, regulatory compliance, team capability and data driven risk management. You will also play a key role in supporting capital engineering projects across the region, ensuring new and existing assets meet the highest technical and compliance expectations to enable right first time manufacturing. Close collaboration with leaders in Manufacturing, Quality, Engineering and Science and Technology at local, regional and global levels will be essential.**Tasks and responsibilities are, but not limited to*** 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, providing microbiology and contamination control leadership under the AH Quality Management System.* Lead 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.* Stay current with relevant regulations, guidelines, and industry standards.* Build strong cross functional and cross-regional relationships, including close partnership with Human Health colleagues to share learnings and align best practices.**Your profile*** Bachelor’s or Master’s degree in a relevant scientific or technical field, such as 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) is highly desirable.* 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.* Living within reasonable distance of mentioned AH locations.**What we offer**This role provides a rare opportunity to leverage strategic leadership skills and aseptic expertise to shape the future of sterile manufacturing across Europe and the Asia Pacific region. You will directly influence Aseptic Excellence across a global network and play a key role in strengthening sterile capability within Animal Health. Benefits vary by location but are highly competitive in all cases. The minimum annual salary for this position in Austria is €110.700,- and varies according to the qualifications and experience of the successful candidate.**Animal Health**Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.Through our commitment to The Science of Healthier Animals(R), we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.**For questions about this vacancy**Please send an email including the vacancy number and job title to the following email address: View email address on click.appcast.io can only be submitted via our careers site.**Required Skills:**Aseptic Manufacturing, Change Leadership, Contamination Control, Contamination Investigation, Driving Continuous Improvement, High Performance Team Building, Innovation, Leadership, Manufacturing Processes, Manufacturing #J-18808-Ljbffr MSD Malaysia
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