- 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
- Bristol Myers Squibb (Madison, NJ)
- …External Manufacturing, Regulatory Affairs and Brand teams. The individual provides end-to-end global quality oversight of all cell therapy development programs ... for cell therapy commercial, clinical and development products. + Acts as lead Quality management reviewer/approver of regulatory submissions and responses to… more
- Merck (Rahway, NJ)
- …assigned projects including clinical supply disposition commitments and maintenance of a current GMP posture within Global Development Quality . + Adhere to ... other applicable worldwide regulations and our Company procedures. Collaborates with the Quality Program Lead to issue reports summarizing results, works with… 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
- Sanofi Group (Pearl River, NY)
- **Job Title:** Sterility Assurance Lead - Contamination Control **Location:** Pearl River, NY **About the Job** We deliver 4.3 billion healthcare solutions to people ... : You'll be working closely with the Head of Quality to ensure the effectiveness of the Contamination Control...participate in the development of strategies for on-site and global continuous improvement projects. This role works closely with… more
- Merck (Rahway, NJ)
- **Job Description** This position reports to the Associate Director, Global Clinical Supplies Quality and is critical to maintaining the global clinical ... experience in the pharmaceutical or equivalent industry Good Manufacturing Practice ( GMP ) related field including Technical, Engineering, Quality or Operations.… 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
- Merck (Rahway, NJ)
- …strong working knowledge of microbiology laboratory practices and procedures in a GMP environment including microbiology data review and quality procedures. This ... passion for improving human health. As part of our global team, you will have the opportunity to collaborate...biologic, and vaccines finished drug products. + Troubleshoot and lead any investigations associated with GMP testing… 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
- Pfizer (Pearl River, NY)
- …This is a laboratory-based role in which the incumbent will lead development of state-of-the-art mammalian cell culture and bacterial fermentation processes ... upstream process in bioreactors to enhance growth, product yield and quality . Experience with AMBR250/bioreactor/WAVE systems is essential. The position also… more
- Actalent (Bronx, NY)
- Production Engineer - GMP Manufacturing A leading health and wellness manufacturer is seeking a Sr. Production Engineer with 7+ years of GMP (drug or food) ... validate the impact of implemented changes Continuous Improvement + Lead Lean Six Sigma projects to reduce waste and...Manage projects and coordinate with internal and external stakeholders Quality & Compliance + Investigate root causes of … more
- Danaher Corporation (New York, NY)
- …career. Learn about the Danaher Business System which makes everything possible. The Lead Quality Assurance Engineer for Cytiva is responsible for various ... level processes and procedures and responsible for following the Global process and procedures effectively within our Quality...service while creating and routing complex changes in our Quality System + Lead or support … more
- Bristol Myers Squibb (Summit, NJ)
- …medicines of tomorrow based on the cutting - edge science of today. Working within Global Product Development and Supply this team uses state - of - the art ... e xecute analytical and CMC strategies that ensure safety, quality and efficacy of life - saving medicines administered...candidate will be part of the Analytical Regulated Testing GMP team at BMS New Jersey within Analytical Strategy… more
- Merck (Rahway, NJ)
- …stakeholders, subject matter experts, and customers both within and outside of Global Clinical Supply (GCS). Your leadership will be instrumental in driving ... readiness for the expanding landscape of on-site clinical capabilities. + Lead efforts to sustain inspection readiness by implementing standardized workstreams. +… more
- Merck (Rahway, NJ)
- …data analytics/visualization software. + Familiarity with Good Manufacturing Practices ( GMP ) requirements, quality procedures, and Standard Operating Procedure ... **Job Description** The Global Clinical Supply (GCS) organization is accountable for...internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.… more
- Mondelez International (East Hanover, NJ)
- …of goods sold eg route to market, capacity utilization, DIOH, manufacturing efficiency, quality , safety. Lead AR development. + Manage and deliver assigned ... You Ready to Make It Happen at Mondelēz International?** **Join our Mission to Lead the Future of Snacking. Make It Uniquely Yours.** This role is responsible for… more
- Merck (Rahway, NJ)
- …creativity, effective interpersonal and collaborative skills + Demonstrated ability to lead teams to deliver high- quality results against firm deadlines ... 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
- Wolters Kluwer (New York, NY)
- …month in the office (see approved locations on the posting). **OVERVIEW** You will be the global product quality lead in support of a broad portfolio of ... + Manage and guide system testing activities, including verification and validation. + Lead resolution of quality issues with on-market device software; drive… more
- Sanofi Group (Ridgefield, NJ)
- …include cleaning and sanitization of process equipment. We are an innovative global healthcare company with one purpose: to chase the miracles of science ... is expected to act on and demonstrate the Sanofi LEAD competencies: + **Act for Change:** Embrace change and...High School Diploma + 2 years Aseptic Processing & GMP environment OR Bachelor's degree + 1 years Aseptic… more