US Quality Network, Transfer & New Product Commercialization Lead
Merck
Merck seeks an Associate Director to lead quality strategy for new product commercialization and technology transfers across manufacturing sites. The role encompasses quality oversight from late development through launch and lifecycle management, with accountability for analytical strategy, compliance, and network efficiency.
Responsibilities
- Develop and execute quality strategy including analytical approaches for new products and transfers across the value chain
- Provide quality leadership from late development through commercialization, inspection readiness, and lifecycle management
- Develop and implement optimal quality testing strategies balancing CAPEX reduction, asset utilization, and platform optimization
- Manage complex transfer quality projects with focus on milestone delivery and compliance with GMP standards
- Partner with global functions including regulatory affairs, supply chain, and R&D to support timely network activities and handovers
Requirements
- Bachelor's degree in chemistry, pharmacy, biology, veterinary science, or related discipline
- Minimum 7+ years pharmaceutical industry experience with biological products and site-based operations
- Demonstrated knowledge of USDA and EU GMP regulations and their operational application
- Lean certification or green belt in continuous improvement minimum
- Project management expertise with ability to drive change in complex organizations
- Strong communication and influencing skills across technical and management levels
- Self-motivated learner with capability to apply new concepts and train others
Vacancy posted 7 days ago
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