- Legend Biotech USA, Inc. (Raritan, NJ)
- …transitioning from clinical to commercial phase GMP operations .Partners with other internal and external Quality Heads to ensure harmonization and alignment ... multiple myeloma.Legend Biotech is seeking a Senior Director of Quality Operations as part of the ...transition activities and responsibilities for Legend.Key ResponsibilitiesServes as the Quality Lead in support of cell therapy… more
- Merck & Co. (Durham, NC)
- …Skills: Minimum of five (5) years of manufacturing, technology, laboratory, and/or quality operations experience within GMP environment GMP Compliance knowledge ... Job DescriptionThe Quality Associate Director/GMP Lead Site Auditor...Site Auditor will have leadership responsibility for the site internal audit program, encompassing the full scope of site… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implementation in the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery- Lead the CRO and ... around rare diseases and immune disorders. SummaryThe Study Delivery Lead (SDL) leads the cross functional core and extended...end-to end delivery of the clinical trial with consistency, quality and per planned timelines. The SDL has the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and ... treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality ...independently and also in a collaborative team setting with quality counterparts that include Manufacturing Operations , … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … and complaint product supply.Key Responsibilities Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ.… more
- Merck & Co. (Rahway, NJ)
- …our US Animal Health enterprise.- Reporting to the Executive Director of Business Operations , this individual will lead a team that will champion ... Management and/or related discipline.5-10 years of experience with back-end customer operations , including post sale support, issue resolution, internal process… more
- Merck & Co. (Rahway, NJ)
- …and act as technical SME supporting next-level operational challenges with our internal and external partner operations .- This individual will also collaborate ... Regions, and External Partnerships & Supply (EPS).- The technical lead owns business continuity of GCS facilities and equipment...regularly with upstream operations (eg manufacturing, devices) as well as … more
- Insmed Incorporated (NJ)
- …Veeva Quality Management System to ensure alignment with regulatory and internal quality standards.Work closely with Quality Assurance, Regulatory ... managing the Quality Management System (QMS) for the entire Technical Operations department.What You'll Do: In this role, you'll have the opportunity to manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …continuous improvement in collaboration with other QA functions and/or applicable stakeholders. Support/ lead and or co lead due- diligence assessments of GMP ... necessary. Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or CMOs. The… more
- Formation Bio (New York, NY)
- …the product development lifecycle. Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and ... external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the...history of effectively collaborating with senior scientific, medical, and operations staff. Demonstrated ability to lead and… more
