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Quality Network Lead, Transfer & New Product Commercialization
MSD. Develop, execute, and implement Quality strategy, including Product Quality analytical strategy, for new product commercializations and transfers across the value chain .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Strategy Development and Implementation, with a strong focus on compliance with GMP and Animal Health Quality Standards. Proven ability to manage complex projects and drive change within organizations while ensuring successful product commercialization and transfer.
Highest-signal resume keywords
Quality Strategy DevelopmentGMP ComplianceProject ManagementAnimal Health Quality OperationsChange Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality LeadershipAnalytical StrategyBiologics KnowledgeTechnology TransferManufacturing Process EfficiencyQuality Assurance Release ProcessesQuality SystemsCommercializationRisk ManagementProgram-Level Quality Performance
Soft Skills
Strong CommunicationInfluencing AbilitiesTask-Oriented LeadershipSelf-MotivatedInclusive
Certifications & Qualifications
MPS CertificationContinuous Improvement Certification
Industry Keywords
Pharmaceutical IndustryBiological ProductsUSDA RegulationsEU GMP GuidelinesAnimal HealthCGMP PracticesVaccine ManufacturingBiopharmaceutical IndustryCMC BiologicsQuality Operations
About the role
Key responsibilities & impact- Develop, execute, and implement Quality strategy, including Product Quality analytical strategy, for new product commercializations and transfers across the value chain
- Provide Quality leadership from late development through commercialization, inspection readiness, launch, and lifecycle management
- Participate in complex strategy evaluations involving technological transfer and analytical transfer of biomaterials
- Drive Quality network strategy development and implementation
- Develop and implement quality and testing strategies that minimize CAPEX, maximize asset utilization, and strategically use analytical platforms and knowledge
- Develop Quality positions for filings and launches
- Drive efficiency, reliability, program-level quality risk and performance, business continuity, and reliability
- Support timely execution of network activities and new product commercializations
- Ensure successful handover to Analytical Technology Solutions for analytical and biomaterial transfers
- Develop and oversee compliance with network and transfer quality activities affecting Animal Health
- Develop and present quality business cases for strategic actions
- Lead activities from quality strategy through transfer execution and report progress to governance bodies
- Work closely with Senior Specialists, Network Transfer
- Apply Animal Health Quality Manual and Quality Standards guidance; design, implement, and maintain GMP and Animal Health Quality Standards
- Manage milestone delivery and prioritization of complex transfer Quality projects involving Quality Assurance Release processes and Quality systems
- Partner with Global Transfer, Global Supply Chain, Bioprocess Technology Solutions, R&D, Aseptic Process Solutions, Global Regulatory Affairs, and other support functions
- Support collaboration and exchange of preferred cGMP practices across the network
Requirements
What you’ll need- 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 and EU GMP regulations, guidelines, and expectations in daily operations
- MPS or continuous improvement certification (green belt minimum preferably)
- Proven ability to manage complex projects
- Strong ability to initiate and drive change within complex organizations
- Broader understanding of complex Animal Health Quality Operations
- Knowledge of biologics, biopharmaceutical industry, CMC biologics, commercialization, manufacturing, process efficiency improvements, project management, quality leadership, quality operations, quality strategy, technology transfer, and vaccine manufacturing
- Strong communication and influencing abilities
- Task-oriented leadership and ability to drive project sponsorship and gain support and resources
- Self-motivated, self-sufficient, and inclusive
- Valid driving license required
- No visa sponsorship
- Willingness to travel 25%
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Hybrid work arrangement