- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- The Director , Global Product Quality , GMP Processes is a strategic leadership role responsible for **benchmarking, standardizing, and optimizing ... continuous improvement** across all regions and product lines. The Director will lead global initiatives to harmonize...operational efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (eg,… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- **Job Summary** The Associate Director , Global Product Quality - Biologics is responsible for directing quality oversight of clinical and commercial ... product integrity while optimizing operational efficiency. + Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- The Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company's ... + **Compliance & Documentation** + Ensure supplier compliance with global regulatory requirements (eg, FDA, EMA, ICH). + Prepare..., with 2+ years in supplier or external manufacturing quality . + Strong knowledge of GMP regulations… more
- Taiho Oncology (Princeton, NJ)
- …MAA's, INDs, CTAs, DMFs, ASMFs, etc. and ensures that they conform to current GMP and meet global regulatory requirements. The incumbent may participate in ... Directs and coordinate regulatory activities of external consultants in consultation with Global Executive Director or designee. + Prepare project and/or status… more
- Honeywell (Hamilton, NJ)
- …and quality . Operating within a matrixed organization, the Sr Director will collaborate across functions and geographies to deliver customer-centric solutions ... The **Sr Director of Software Sales - Life Sciences** will...process development to commercial scale-up + Demonstrated knowledge of quality systems and regulatory frameworks (eg, GMP ,… more
- Sumitomo Pharma (Trenton, NJ)
- …Director , Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the ... Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations...are implemented and updated for all development and commercial GMP programs. The individual must have the ability to… more
- Integra LifeSciences (Princeton, NJ)
- …outcomes and set new standards of care. Under direct supervision of Director , Quality Reliability Microbiology, the Sr. Manager, Microbiology Reliability - ... a medical device manufacturing environment. This position reports into Global Laboratories, Microbiology, and Sterility Assurance but will be...13485, ISO 14644, ISO 14698, BS EN 17141, EU GMP Annex 1, ISO 11135, ISO 11764, ANSI/AAMI ST98,… more
- Catalent Pharma Solutions (Princeton, NJ)
- …that meet or exceed client expectations. The Program Manager will report to the Director , Global Project and Portfolio Management. **Catalent is committed to a ... **Program Manager** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop,… more
- Stantec (New York, NY)
- …us create buildings that matter to our world. Together, we are enhancing the quality of life globally through design. Join us and design your place with Stantec. ... FDA or similar facilities where drug products are manufactured, stored in GMP conditions and distributed, including computerized and automated systems which require… more
- Hovione (East Windsor, NJ)
- …with the Senior Director of the area - Coordinate with the global regulatory, production, and R&D groups to provide a superior level of customer service ... negotiation of long-term contracts including (but not limited to) sales contracts, quality agreements and development agreements - Identify market trends and demands… more