Your role
The Director, Global Contamination Control Strategy leads the development, harmonization, and stewardship of microbiological, viral, and environmental contamination control programs across Merck's global manufacturing network, including internal sites and third-party manufacturers (TPMs)/CDMOs. This position reports to the VP, Head of Global Quality Compliance. Acting as the senior global technical authority for contamination control, the successful candidate defines microbial and viral control strategy in close partnership with global and local Engineering, Manufacturing Science and Technology, Quality Control, and Quality Assurance functions, and provides technical direction for new facility start-ups as well as ongoing network operations.
The role owns network-level frameworks such as the global Contamination Control Strategy (CCS) methodology, Environmental Monitoring and Cleanroom Performance Qualification (CPQ) standards, contamination FMEA methodology, and contamination response playbooks – establishing a Center of Excellence approach that provides consistent technical direction while allowing for site-specific risk assessment. The Director will build and lead a team of technical experts, mentor site-level microbiology and contamination control staff across the network, and drive continuous improvement through new technologies, digital plant capabilities, and Process Analytical Technology (PAT).
Key Responsibilities
- ✓Develop and execute a multi-year global roadmap for contamination control and sterility assurance across biologics, small molecules, sterile fill-finish, ADCs, and new modalities.
- ✓Author and maintain global contamination control standards, CCS, EM/CPQ methodology, and contamination FMEA, ensuring harmonized practices reflecting applicable guidance.
- ✓Act as the leading global SME for contamination control and sterility assurance across the network and third-party manufacturers (TPMs)/CDMOs, including during health authority inspections.
- ✓Establish and own the global Environmental Monitoring and CPQ framework, contamination FMEA methodology, 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.
- ✓Partner with network sites, R&D, and technical development to develop and transfer a robust microbial/viral control strategy across sites; maintain virology controls expertise.
- ✓Lead and develop the contamination control/microbiology team; share best practices with site teams and senior management.
- ✓Guide cross-functional investigations and trend analyses (water systems, environmental monitoring) to mitigate supply disruptions; apply statistics to define specs and plans.
- ✓Ensure MES/EBR integration for process parameter and monitoring requirements to support regulatory consistency.
- ✓Contribute to global regulatory submissions and responses to health authorities; drive network-wide process improvements including Lean and digitalization.
Who you are
- ✓10+ years in sterility assurance, industrial microbiology, or contamination control within a GMP manufacturing environment, 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.
- ✓Willing and able to travel internationally (approximately 20–30%).
- ✓Data-driven with a track record of cross-site collaboration and driving improvements without direct authority.
- ✓Strong interpersonal, verbal, and written communication skills 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.
Department: HC-GM-QM Global Quality Compliance
Job evaluation: Expert 4