- Genmab (Plainsboro, NJ)
- …depending on the role for the assigned product Consult with senior management to develop and communicate regulatory strategies and advice for products and ... (in line with Target Product Profile). For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Boston Global Development leadership team on occasion. May interact with senior leaders/leadership, on occasion. Essential Functions Stakeholder Management : ... lives for a living. Are you ready to make a difference? The Position The Senior Global Medical Manger plays a critical role in supporting the strategic objectives of… more
- Formation Bio (New York, NY)
- …activities, including specification development, manufacturing, product release, stability programs, change management , and vendor oversight. The Sr. Director ... product manufacturing/packaging and release, stability program design and execution, change management processes, vendor selection and internal and… more
- Novo Nordisk Inc. (Durham, NC)
- …DV/CAPA, Change Control, Audits, Supplier Management , Project Management , Validation, etc.) required Experience with regulatory requirements computer ... of batch reports & release of incoming materials, deviations, change controls, review & approval of SOPs, QA presence...support all processes & functions in Department Quality Risk Management Make decisions on quality & compliance issues with… more
- Novo Nordisk Inc. (Durham, NC)
- …DV/CAPA, Change Control, Audits, Supplier Management , Project Management , Validation, etc.) required Experience with regulatory requirements computer ... of batch reports & release of incoming materials, deviations, change controls, review & approval of SOPs, QA presence...support all processes & functions in Department Quality Risk Management Makes decisions on quality & compliance issues with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …overall compliance requirements for the Utilities areas, including SOPs, change control, quality investigations and CAPAs.Support the Production Operations in ... is maintained to meet GMP requirements.Support utilities areas in Regulatory / FDA inspections ensuring successful outcomes.Cross functional collaboration with… more
- Novo Nordisk Inc. (Durham, NC)
- …Mindset that focuses on risk management & mitigation Implement effective Change Management Support Corporate, OFP, local IT & local stakeholder initiatives ... process control systems to meet current & projected customer, business & regulatory requirements through the following activities: People Focus, Equipment Focus &… more
- Cytiva (Miami, FL)
- …changes, advocate for site-specific needs, and drive customer-centric solutions during change management initiatives.Team Development & Performance: Build a ... do:Quality Leadership & Compliance: Serve as the Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a future focused approach, leveraging competencies, tools and technology, and with change management skills. Relationships Reports into NACD Therapy Area Head. ... , team collaboration, training and development, employee engagement, and recognition Change Management : Identifying areas for improvement in operational… more
- Novo Nordisk Inc. (Durham, NC)
- …Master's degree preferred Minimum of ten (10) years' experience in a senior management role in biotech and/or pharmaceutical manufacturing environment required, ... in English required Proven expertise in mentoring/development, process confirmation, change management , planning/organizing, managing execution are required… more
