Epic MyChart/Cadence Analyst

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 Product Quality analytical strategy for NPC’s and transfers across the value chain. Provides quality leadership from late development through commercialization, inspection readiness, launch, and lifecycle management. This multifaceted role 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:

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., Paving Timelines Operations Leadership Management Governance Innovation Scalability Communication Change Control Data Migration Risk Mitigation Time Management Team Leadership Solution Design Digital Banking Technical Issues Release Management Business Valuation Financial Services Industry Standards Business Strategies System Requirements Lifecycle Management Business Requirements Information Technology Full Stack Development Business Transformation PeopleSoft Applications Oracle Fusion Middleware Customer Relationship Management +0 Epic MyChart/Cadence Analyst TEKsystems

Kansas City, MO*Remote

Epic EMR Scheduling Operations Epic Cadence Epic Mychart Business Valuation Workflow Management Full Stack Development Business Transformation +0 2027 Future Talent Program - Animal Health Retail Sales - Intern Merck & Co., Inc

Lenexa, KS*On-Site

Sales Energetic Leadership Innovation Agriculture Retail Sales Merchandising Animal Health Plan Execution

Vaccines Chemistry Operations Leadership Management Governance Innovation Compassion Reliability Supply Chain Communication Animal Health Prioritization Pharmaceuticals Quality Strategy Telephone Skills Quality Assurance Commercialization Biopharmaceuticals Project Management Regulatory Affairs Quality Management Aseptic Processing Business Continuity Technology Transfer Capital Expenditure Project Sponsorship Technology Solutions Contingent Workforce Lifecycle Management Six Sigma Green Belt Strategy Development Self-Directed Learning New Product Development Product Quality (QA/QC) Good Manufacturing Practices Continuous Improvement Process, Required

• 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.

Required Skills: Biologics, Biopharmaceutical Industry, CMC Biologics, Commercialization, Manufacturing, Pharmaceutical Industry, Process Efficiency Improvements, Project Management, Quality Leadership, Quality Operations, Quality Strategy, Technology Transfer, Vaccine Manufacturing, Animal Science Microsoft Excel Customer Service Telephone Skills E-Commerce Sales Computer Literacy Selling Techniques Business Marketing Customer Engagement Medical Prescription Microsoft PowerPoint Contingent Workforce Strategic Prioritization Interpersonal Communications Ethical Standards And Conduct

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The salary range for this role is $142,400.00 - $224,100.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.