US Quality Network, Transfer & New Product Commercialization Lead

Merck • Millsboro, DE

11d • $142,400 - $224,100 • Hybrid

About The Position

As the Quality Network, Transfer and New Product Commercialization (NPC) Lead, you are accountable for the development, execution, and implementation of the Quality strategy, including the Product Quality analytical strategy for NPC's and transfers across the value chain. This role provides quality leadership from late development through commercialization, inspection readiness, launch, and lifecycle management. It includes participating in increasingly complex strategy evaluations, where Science & Technology (StS) is responsible for overall project management/technological transfer and Analytical Technology Solutions (ATS) is responsible for the analytical transfer/transfer of biomaterials. As a member of the Excellence Quality Team, the Associate Director drives Quality network strategy development and implementation.

Requirements

• Bachelor's degree in chemistry, Pharmacy, Biology, Veterinary, or related scientific discipline.
• Minimum 7+ years experience in Pharmaceutical Industry with Biological products, including site-based Operations manufacturing or Quality.
• Proven knowledge and understanding of USDA, EU GMP regulations, guidelines, and expectations in their application in daily operations.
• MPS or continuous improvement certification (green belt minimum preferably).
• Strong communication and influencing abilities.
• Proven ability to manage complex projects.
• Strong ability to initiate and drive change within complex organizations.
• Learning ability: autodidactic, actively learning new concepts, applying in practice, and training others.
• Effective communication skills to different target groups (technicians, management, and peers) and across boundaries.
• Task-oriented leadership: ability to drive project sponsorship and gain support and resources.
• Focus on results: drives results based on strategy and customer needs.
• Self-reflection: actively looking for feedback and translating this to personal development actions.
• Broader understanding of complex (Animal Health) Quality Operations.
• Self-motivated, self-sufficient, inclusive.
• Biologics
• Biopharmaceutical Industry
• CMC Biologics
• Commercialization
• Manufacturing
• Pharmaceutical Industry
• Process Efficiency Improvements
• Project Management
• Quality Leadership
• Quality Operations
• Quality Strategy
• Technology Transfer
• Vaccine Manufacturing

Nice To Haves

• Preferred Skills: Current Employees apply HERE
• Current Contingent Workers apply HERE

Responsibilities

• Accountable for the development, execution, and implementation of the Quality strategy including Product Quality analytical strategy for NPC’s and transfers across the value chain.
• Provide quality leadership from late development through commercialization, inspection readiness, launch, and lifecycle management.
• Participate in increasingly complex strategy evaluations, managing overall project management/technological transfer and analytical transfer/transfer of biomaterials.
• Drive Quality network strategy development and implementation.
• Develop and implement an optimal quality and testing strategy delivering minimized CAPEX, maximized asset utilization, and strategic usage of analytical platforms and knowledge.
• Ensure optimal usage of workforce and analytical knowledge base, developing Quality positions for filings & launches.
• Drive efficiency and reliability, program level quality risk & performance, minimizing risk, and ensuring business continuity and reliability.
• Support the timely execution of network activities and NPC’s.
• Ensure successful handover to ATS for the analytical transfer/transfer of biomaterials.
• Develop and oversee compliance to all network and transfer quality activities and NPC’s impacting Animal Health.
• Develop and present quality business cases for strategic-related actions.
• Lead activities from quality strategy to transfer execution by StS/ATS and report progress to governance bodies.
• Work closely with Sr Specialists Network Transfer.
• Apply Animal Health Quality Manual /Quality Standards guidance for Animal Health projects; design, implement, and maintain GMP and Animal Health Quality Standards during transfers and NPC’s.
• Manage and ensure milestone delivery and prioritization of complex transfer Quality projects regarding Quality Assurance Release processes and Quality systems.
• Partner with other global support functions such as Global Transfer teams, Global Supply chain, Bioprocess Technology Solutions, R&D, Aseptic Process Solutions, Global Regulatory Affairs, and others as appropriate.
• Support and ensure collaboration and exchange of preferred cGMP practices across the network.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior