Regional Lead Aseptic Excellence (pharma)

Merck Merck · Pharma · North Brabant, Netherlands

Regional Lead Aseptic Excellence for Merck's Animal Health organization, focusing on sterile manufacturing, microbiology, and contamination control across Europe and Asia Pacific. The role involves leading a team, driving improvement projects, ensuring regulatory compliance, and supporting capital engineering projects.

What you'd actually do

  1. Lead, coach and develop the regional APS team, building technical, microbiological and leadership capability.
  2. Contribute to the deployment of the APS and S&T Excellence strategy across Europe and the Asia Pacific region.
  3. Define, implement and continuously improve aseptic practices, policies and procedures in partnership with Operations, Engineering, Quality, Research and Development and other S&T functions.
  4. Drive operational excellence through process optimization, automation, best practice deployment, and right first-time technology transfer and asset introduction.
  5. Provide expert microbiology and contamination control support to sterile and non-sterile sites across the internal and external network.

Skills

Required

  • Bachelor’s or Master’s degree in a relevant scientific or technical field
  • Extensive industry experience in sterile manufacturing
  • Proven track record of increasing responsibility and leadership
  • Strong understanding of aseptic manufacturing principles and biologics/sterile processes
  • Strong leadership capabilities
  • Demonstrated success in stakeholder management
  • Solid experience with regulatory expectations and compliance in a highly regulated environment
  • Proven ability to lead sites through successful regulatory inspections
  • Strong change management skills
  • Strategic thinker
  • Excellent communication and collaboration skills
  • Innovative mindset

Nice to have

  • exposure to FDA, USDA, EMA Annex 1, and other relevant international guidelines

What the JD emphasized

  • extensive industry experience in sterile manufacturing
  • proven track record of increasing responsibility and leadership
  • Strong understanding of aseptic manufacturing principles
  • Solid experience with regulatory expectations and compliance in a highly regulated environment
  • Proven ability to lead sites through successful regulatory inspections