- 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 Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems … more
- Merck & Co. (Rahway, NJ)
- …Business Systems , Change Management, Content Management, Content Management Systems (CMS), Cross-Cultural Awareness, Data Management, Data Quality ... ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The… more
- Merck & Co. (Rahway, NJ)
- …of 6 years of experience in pharmaceutical development, device development, device systems operations, quality management, or a related area. Strong knowledge ... Job DescriptionThe Senior Scientist, Device Risk Management Lead , is a crucial member of our team,...device risk management activities to ensure the delivery of high- quality products and efficient manufacturing processes. The role requires… more
- Merck & Co. (Rahway, NJ)
- …Machine Learning (ML), Manufacturing Processes, Mechanical Testing, Medical Device Quality Systems , Medical Device Regulations, Medical Devices, Medical ... medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.--… more
- Merck & Co. (Rahway, NJ)
- …Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for ... molecule bulk and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to be an industry leader in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and ... Systems COE, the Director, Global Distribution Engineering and Technology,...for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics… more
- Formation Bio (New York, NY)
- …them for regulatory inspections. Overseeing the development, implementation, and upkeep of quality systems and procedures, including SOPs, batch records, and ... and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the...requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of… more
- ValSource, Inc. (Rahway, NJ)
- …projects directly at client sites, ensuring that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves ... currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting… more
- Merck & Co. (Rahway, NJ)
- …Operations Technology product line (supporting applications related to Workflows, Planning, Quality , Compliance, Vendor Management) you will spend a lot of time ... IT applications. You will work side by side with Product Line Lead , Software engineers, Architects, UX designers, Business Analyst, Technical Project Manager,… more
- Merck & Co. (Rahway, NJ)
- …SOPs for all GxP automation systems . Lead integration of control systems with MES, Quality , and Batch Reporting applications.Understand and adhere to CFR, ... improvements, etc.), changes to support new products, and maintaining the automation systems in compliance with cGMP- Lead automation related investigations into… more
- Merck & Co. (Rahway, NJ)
- …Sciences colleagues.-Recommends and executes programs of value to the Company which lead to availability of Clinical Supplies and Development Batches to meet ... Clinical Development Program requirements.-Partners with Quality , Operations, Technology, and Financial to value these efforts to develop cost standards for new or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and establish transition activities and responsibilities for Legend.Key ResponsibilitiesServes as the Quality Lead in support of cell therapy manufacturing and ... team based in Raritan, NJ.Role OverviewThe Sr. Director of Quality will lead Legend CAR-T manufacturing facilities...exceptional team to manage the Quality functions ( Quality Assurance, Quality Systems , … more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... testing and qualification and leading execution of qualification of complex systems .-The candidate is expected to build inclusive, collaborative partnerships with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OOS monitoring and trending program)Contribute to developing and/or improvements to quality systems in support of global implementation of changes ... initiatives.Experience in developing, writing and approving technical documents.Experience with Quality systems (Change control, investigations, LIMs, etc.).Extensive… more
- Merck & Co. (Rahway, NJ)
- …a best-in-class patient experience for IBD patients in support of the launch of our lead asset in immunology. This role will develop a deep understanding of the IBD ... standards.- The Director will collaborate closely with the US patient support strategy (PSP) lead where relevant, with an aim to ensure the scope and scale of… more
- Merck & Co. (Rahway, NJ)
- …and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality , and Supply Chain from early development through to commercial ... and information to others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in the best interest of… more
- Merck & Co. (Rahway, NJ)
- …modalities. We are interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with our partners in ... seasoned Project Manager with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on helping the team build… more
- Merck & Co. (Rahway, NJ)
- …control environment at our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management supervision in addition ... papers (including walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in the writing of… more
- Formation Bio (New York, NY)
- …initial screen through confirmatory diligence and integration. This role will lead late-stage diligence efforts, support asset onboarding post-acquisition, and help ... milestones until steady-state ownership is established.Key ResponsibilitiesDiligence Program Management Lead and manage the full diligence process from initial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …help the team, in a manner consistent with safety policies, quality systems , and cGMP requirements.Support manufacturing investigations, create/revise ... records and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead the daily start of shift operations meetings, the daily wrap up… more
