- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in ... Legend Biotech is a global biotechnology company dedicated to treating, and one...Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with responsibilities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …methodologies to lead an efficient and effective organization Support the global quality annual objectives, strategic initiatives to deliver against the ... direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global Quality teams located in EU, Americas (including Brazil)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis role is key leadership position within Global QMS and Global Quality Assurance. Overall accountability is ... for the development of document and record management principles for Global GxP activitiesResponsibilitiesTraining Function Team Lead development of strategies… more
- Merck & Co. (Rahway, NJ)
- …projects including clinical supply disposition commitments and maintenance of a current GMP posture within Global Development Quality .Adhere to cGMPs ... worldwide regulations and our Company procedures. They will also collaborate with the Quality Program Lead to issue reports summarizing results, works with area… more
- Merck & Co. (Rahway, NJ)
- …skills, demonstrated creativity, effective interpersonal and collaborative skillsDemonstrated ability to lead teams to deliver high- quality results against firm ... technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate...the Raw Materials and Medical Devices/Combination Products (MDCP) will lead a team of specialists and scientists in Rahway… more
- Merck & Co. (Rahway, NJ)
- …Mindset - Demonstrated ability to deliver compliant supply and achieve highest quality , lowest cost, and shortest lead -time. Strategic Thinking - Ability ... Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for...and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Quality Lead , GMP , GDP Audit and Inspection - Pipeline Launch **Location:** Framingham, MA or Morristown, NJ **About the Job** We ... in Sanofi. + **Scope:** Manufacturing & Supply, Research & Development, Countries, Digital, Global Quality organizations in Sanofi. And third parties outside of… more
- Berry Global (Monroe, NJ)
- …by First Article and In-Process Inspection procedures and assigned by the Lead Inspector. Follow all work instruction related to in process inspection. 3.2 ... Conduct daily dimension as required by department procedures, or Lead Inspector. 3.3 Clearly document Inspection results on Inspection sheets maintaining GMP … more
- Merck (Rahway, NJ)
- …assigned projects including clinical supply disposition commitments and maintenance of a current GMP posture within Global Development Quality . + Adhere to ... worldwide regulations and our Company procedures. They will also collaborate with the Quality Program Lead to issue reports summarizing results, works with area… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …3 years in risk management leadership position. + Expertise in GMP compliance, Quality System and global GMP regulations + Must have strong knowledge ... personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Director, Quality Risk Management will drive consistent Global Leadership… more
- Catalent Pharma Solutions (Bridgewater, NJ)
- **Job Title: Global Director, Continuous Improvement** **Location: Bridgewater, NJ** **Position Summary** The focus of this role will be identifying and implementing ... and late-stage clinical products efficiently, timely, and with high quality . Scope of the role covers the entire product...delivery of the cost transformation across the company. The Global Director Continuous Improvement will be part of the… more
- Bristol Myers Squibb (Summit, NJ)
- …better place than here at BMS with our Cell Therapy team. The ** Lead Project Engineer, Equipment Commissioning and Qualification (ECQ)** Delivery, plays a key role ... to meet business needs in accordance with required schedules or dates. + Lead and oversee contract project teams to ensure timely execution and adherence to… more
- Bristol Myers Squibb (Summit, NJ)
- …as the Global Technical SME for Drug Product and Vector Validation. The lead will develop global technical standards for cell therapy validation and deploy ... providing SME assessment for proposed process life-cycle changes. The lead will serve as the Global Point...global cell therapy validation technical standards via the quality system. + Promote innovative and efficient approaches to… more
- Lilly (Branchburg, NJ)
- …to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work ... we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards… more
- Actalent (Princeton, NJ)
- …Essential Skills + 3+ years of cell therapy experience. + 3-5 years of GMP manufacturing experience. + Quality Assurance oversight for manufacturing floors. + ... deviation identification. + Ensure all manufacturing activities comply with GMP and regulatory requirements. + Review and approve ...Fishbone diagrams, 5 Whys, and FMEA. + Ability to lead and close complex quality investigations. +… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …The Vice President of Central Quality Operations will lead and influence Quality strategy for Gilead Global Quality Management System (QMS) and the ... significant impact across many areas as the QMS and Global Market GMP /GDP activities are core to...of findings to key stakeholders, essentially acting as the lead quality expert in ensuring the report… more
- Bristol Myers Squibb (Summit, NJ)
- …GDPs. + Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements. + Works in a team-based, cross-functional ... lives. Read more: careers.bms.com/working-with-us . **Job Title** : Manufacturing Team Lead , Liso-cel CAR-T **Location** : US-NJ-Summit West, S12 **Department** :… more
- Sanofi Group (Morristown, NJ)
- …and high- quality responses and support the development and promotion of Global Quality Documentation. + Supports the preparation, execution and closure of ... purposes, and ensuring accurate reporting to Operations Management and Global Quality . . **Core member of critical.... . **Core member of critical governance** + Sanofi's GMP GDP Quality Council to facilitate sharing… more
- dsm-firmenich (Somerset, NJ)
- **Sr. Team Lead 2nd Shift, Production, PE** **Somerset, NJ, US** This position will lead and coordinate and manage the 3rd shift Production Team, providing ... implementing process improvement initiatives. + Conduct daily audits of Quality Risk Assessments, proactively addressing and preventing non-conformances and utilize… more
- Bristol Myers Squibb (Summit, NJ)
- …place than here at BMS with our Cell Therapy team. The ** Lead Computer System Validation (CSV) Engineer** supports the successful implementation of manufacturing ... while promoting a positive learning, team environment. + Author quality procedures and training documents. + Deliver training on...office environment. Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats… more
