Director, Global Contamination Control Strategy (all genders)

As Director, you will lead the global contamination control strategy across Merck’s manufacturing network, partnering with engineering, science, QA, and TPMs/CDMOs to ensure sterility and microbial control. You will establish a Center of Excellence for environmental monitoring, CPQ, and FMEA, guiding start-ups and ongoing operations. This role drives continuous improvement through new technologies and digital plant capabilities. You will influence regulatory interactions and ensure consistent, risk-based contamination control globally.

• Develop and execute a multi-year global roadmap for contamination control across biologics, sterile fill-finish, ADCs, and new modalities
• Author and maintain global contamination control standards, CCS, EM/CPQ methodology, and contamination FMEA
• Serve as the leading global SME for contamination control and sterility assurance across the network and TPMs/CDMOs
• Establish and own the global EM and CPQ framework, contamination FMEA, and contamination response playbooks; oversee local implementations
• Provide technical and regulatory guidance on facility design, cleanroom engineering, and microbial/particle control for aseptic and low-bioburden areas
• Collaborate with network sites, R&D, and technical development to transfer robust microbial/viral control strategies across sites
• Lead and develop the contamination control/microbiology team; share best practices with site teams and senior management
• Guide cross-functional investigations and trend analyses to mitigate supply disruptions; apply statistics to define specs and plans
• Ensure MES/EBR integration for process parameter and monitoring to support regulatory consistency
• Contribute to global regulatory submissions and responses; drive network-wide process improvements including Lean and digitalization

• 10+ years in sterility assurance, industrial microbiology, or contamination control within GMP manufacturing with leadership experience
• Expertise in EU GMP Annex 1, ISO 14644, USP, PDA technical reports, and related regulatory frameworks for aseptic/low-bioburden manufacturing
• Fluent in English; additional European languages are a plus
• Willingness to travel internationally (approximately 20–30%)
• Data-driven with track record of cross-site collaboration and improvements without direct authority
• Strong interpersonal, verbal, and written communication across cultures and time zones
• Hands-on experience with sterile fill-finish operations and cleanroom/facility qualification
• Experience supporting GMP audits and inspection readiness activities

• strong communication across cultures
• cross-functional collaboration
• leadership and mentoring
• Environmental Monitoring (EM)
• CPQ methodology
• contamination FMEA