- 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)
- … 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
- 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
- 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 of ... 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
- AdaptHealth LLC (Philadelphia, PA)
- …business management, and cross-functional teams including Finance, Legal, IT, and Operations . Lead discussions regarding audit observations and promote awareness ... 2: Senior Internal Audit Auditor Years of Experience: 3-5 years Lead specific audit procedures independently Mentor junior associates Develop audit programs for… 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
- 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
- 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
- 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
- USAA (Plano, TX)
- …and impactful. The Opportunity As a dedicated Business Risk and Controls Advisor Lead , you will be responsible for overseeing and guiding risk management and control ... Privacy, Data & Analytics, Third Party Risk Management, and Resiliency teams. The lead will be instrumental in identifying, assessing, and mitigating risks, as well… more
- MCKESSON (Fort Worth, TX)
- …products are packaged and transported in compliance with industry standards and internal quality requirements. Key Responsibilities Oversee a team responsible ... from you. We are seeking a highly skilled and strategic Senior Manager, Quality Packaging Engineer, to lead the development, validation, and implementation of… more
- Insmed Incorporated (NJ)
- …other third-party providers in alignment with clinical development and Clinical Operations timelinesFoster and manage strategic supplier relationships, lead ... reviewsEstablish and maintain KPIs, scorecards, and governance frameworks for both internal supply operations and external partnersServe as clinical supply… more
- Insmed Incorporated (NJ)
- …and audit readiness, serving as a subject matter expert on medical review operations during internal and external inspections.Who You Are:You have a Bachelor's ... in. Are you?About the Role:The Associate Director, Medical Review Committee (MRC) Operations is responsible for managing the operational execution of the company's… more
- USAA (Colorado Springs, CO)
- …Auto Non Injury Core - Manager, Claims Operations . As a dedicated Manager, Claims Operations , you will lead and be accountable for auto, and other claims ... operations member service employees who are responsible for serving...Complete process improvements, provide feedback on the process and lead organizational process changes. Drive execution of operational risk… more
- Usaa (Charlotte, NC)
- …and building high-performance teams? We are seeking a dedicated Director to lead a large-scale, multi-carrier contact center team serving businesses across all 50 ... performance and product performance through effective management. Collaborates with internal and external partners (alliance carrier underwriting, product management)… more
- Aveanna Healthcare (Madison, WI)
- …resolution processes are executed consistently and efficiently at all branches. Business Operations & Financial Oversight Lead the development and implementation ... operational, and leadership oversight of a primary location while overseeing the operations of up to 4 locations. The AED ensures consistent compliance with… more
- ValSource, Inc. (Worcester, MA)
- …Lines Leadership & Collaboration Lead cross-functional teams across engineering, quality , validation, and operations . Collaborate with Jacobs project teams ... representing the client. Act as facilitator, supervisor and Safety lead ensuring client Safety and Quality standards...working knowledge of GMP systems, equipment qualification, and process operations . Proven ability to lead teams, manage… more
