- 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)
- **Job Summary** The Associate Director Controlled Substances, Quality Global Product Quality - API/DP is responsible for directing quality oversight ... and final finished product) for controlled substances + Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC to… 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
- Oracle (Trenton, NJ)
- **Job Description** Lead the global estimating function for a large-scale, leased data center build program, responsible for end‑to‑end estimating governance, ... change-order assessments, and continuous benchmarking. Establish and maintain the global Cost Breakdown Structure (CBS) and a centralized cost database,… more
- J&J Family of Companies (Raritan, NJ)
- …a member of Johnson & Johnson's Family of Companies, is recruiting for a Director of Quality Control, CAR-T Manufacturing! This position will be located in ... advance the promise of an immunotherapy CAR-T platform and investigational treatment. The Quality Control Director for an Advanced Therapy CAR-T facility leads… more
- BeOne Medicines (Pennington, NJ)
- **General Description:** The Associate Director Quality Control (QC) will lead analytical strategy, method lifecycle management, and QC operations to support ... GMP testing and release of materials, intermediates, and finished...cross-functional collaboration with Regulatory Affairs, Process Development, Manufacturing, and Quality teams, as well as external vendor management. This… 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
- Bristol Myers Squibb (Princeton, NJ)
- …extensively with teams and leaders across the BMS network. The Associate Director will support BMS' GMP /GDP Inspection Readiness strategy by supporting ... based on a risk-based approach. **Key Responsibilities** * Monitor and assess global regulatory inspection outcomes, enforcement actions, quality and compliance… more
- J&J Family of Companies (Raritan, NJ)
- …Builds and sustains strong relationships with internal and external stakeholders, including Global Quality teams, Manufacturing, Quality Control, Facilities ... and management of robust testing programs, risk assessments, and quality systems. The Director will provide technical...virology. The candidate will consult with JNJ manufacturing facilities, Global and Site Quality and Global… more
- ThermoFisher Scientific (Bridgewater, NJ)
- …Join PPD, a part of Thermo Fisher Scientific, as an **Executive Account Director /** **Sr Account Director , Business Development** **Biotech** and take on the ... developing and executing a strategic sales plan to maximize business from your assigned global key accounts. In this pivotal role, you will drive revenue growth by… 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
- BeOne Medicines (Pennington, NJ)
- …computer system assurance across all business domains. + Previous experience in a GMP manufacturing, quality or operations environment validating GxP systems not ... activities and oversee the process for completion according to quality procedures as required. + Assist in performing impact...update and approve all GTS documentation to align with global standards. + Responsible for managing all aspects relating… more
- Catalent Pharma Solutions (Princeton, NJ)
- …and more-to maintain site compliance and drive continuous improvement. The Senior Specialist, Quality Operations will report to the Director , Quality . **The ... **Senior Specialist, Quality Operations** **Position Summary:** + **Work Schedule: Monday...Friday, 8:00am-5:00pm.** + **100% on-site** Catalent is a leading global CDMO, trusted by pharma, biotech and self-care companies… more
- J&J Family of Companies (Raritan, NJ)
- …tools and templates + Assists in regulatory inspection and assist in safety and quality audits + Follow GMP guidelines and safety guidelines and regulations ... thinking, financial acumen, and problem-solving capabilities + Solid understanding of GMP /Regulatory requirements and site Quality systems; exposure to audit… 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
- Integra LifeSciences (Princeton, NJ)
- …performance evaluation process for the responsible categories. Under the direction of the Director of Indirect Goods & Services, Global Procurement, this role ... approximately $100M and savings targets will be set annually by the global procurement organization. The Category Manager will interact with key business… 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