- 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. (Trenton, 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
- Merck (West Point, PA)
- **Job Description** The Global Packaging Procurement Director is responsible to lead the Packaging Center of Excellence (COE) organization. The scope for this ... support overall category management for the packaging category led by the global COE's, either directly (for local managed categories) or indirectly through strong… more
- Merck (West Point, PA)
- **Job Description** The Director , Technical Operations within Global Clinical Supply (GCS) is responsible for technical leadership in support of GCS global ... equipment-based challenges when required. The technical lead may also manage global infrastructure projects to establish, upgrade, and improve the GCS packaging,… more
- Catalent Pharma Solutions (Philadelphia, PA)
- **Associate Director , Quality Assurance** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... a full-time salaried position, onsite out of Philadelphia, PA.** The **Associate Director , Quality Assurance** is responsible for providing leadership and… 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
- Merck (West Point, PA)
- …execution, along with leadership skills to shape the technical capabilities lead a global , cross-modality technical team. The Associate Director will lead a team ... **Job Description** Reporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be… 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
- CSL Behring (King Of Prussia, PA)
- …continuous improvement across CSL Plasma, resulting in efficiency improvements, sustained quality and safety, and lower costs. + Exercises advanced technical ... teams to deliver tangible results. + Working knowledge of FDA regulations including GMP , OSHA and CLIA desirable. + Advancing the culture and mindset of Operational… more
- Merck (West Point, PA)
- …to secondary and tertiary packaging. + Develop working relationships with global company functions, external manufacturing and third-party distribution centers, with ... of eight years of experience in engineering, logistics, planning, procurement, quality , or related disciplines. + Strong interpersonal and leadership skills,… more
- Merck (West Point, PA)
- **Job Description** Reporting into the Director Packaging Platform Technical Leadership the Associate Director Medical Device and Combination Product (MDCP) ... supply of commercialized products for the benefit of patients. The Associate Director of MDCP Platform Packaging and Assembly Technical Leadership is integral 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