- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders.Summary The Manager, Data Privacy & Compliance Investigations , is a member of the Compliance Department ... with applicable privacy laws and regulations; and (b) managing and conducting internal investigations . This position, working with DSI's Data Privacy Officer,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a QA Investigations Lead (1st or 2nd shifts) as part of the Quality team based in ... Raritan, NJ. Role OverviewThe QA Investigations Lead has the responsibilities for providing quality oversight over the production of a personalized cell therapy to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Supervisor (2nd shift) as part of the Quality team based in ... Raritan, NJ. Role OverviewThe QA Investigations Supervisor has the responsibilities for providing quality oversight over the production of a personalized cell… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to ensure the batch release process is not impacted by outstanding deviationsEnsure investigations will comply with internal NN requirements and are compliant ... operational problems as assigned. This position is responsible for leading investigations to ensure the written investigation report contains the technical merit… more
- Merck & Co. (Rahway, NJ)
- …platforms to support digital strategies, process development activities, support compliance investigations /change management, author GMP documentation and ... drug substance and/or biologics process development.Experience in leading or supporting compliance investigations and change management.Familiarity with US and… more
- Merck & Co. (Rahway, NJ)
- …and effectively share this knowledge with othersParticipate in external and internal audits, tours, and inspectionsEnsure closure of investigations , as ... Lead will drive a culture of perpetual adherence to safety and compliance standards. A successful candidate should have extensive drug product process development… more
- Merck & Co. (Rahway, NJ)
- …help drive our Strategic Operating Priorities.Invent - Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical NeedsExecute - ... products globally.Experience in authoring ISO-13485 and 21 CFR 820 compliance technical documents, design controls, device risk management, medical device,… more
- Daiichi Sankyo, Inc. (Boston, MA)
- …responsibilities in a compliant/ethical manner. Handle PHI appropriately by ensuring compliance with HIPPA regulations, laws, and internal company ... of DSI products. ADFR's provide strategic coverage/reimbursement leadership and support to internal DSI leadership and Care Team's to which their geographies align.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …absence and accommodations, background checks and other pre-employment screenings, internal investigations , restrictive covenants, policy development, drafting, ... review and implementation, and restructures); employee benefits (design, implementation, compliance , and governance of ERISA health and welfare plans, pension plans,… more
- Daiichi Sankyo, Inc. (Seattle, WA)
- …responsibilities in a compliant/ethical manner. Handles PHI appropriately by ensuring compliance with HIPPA regulations, laws and internal company ... of DSI products. ADFR's provide strategic coverage/reimbursement leadership and support to internal DSI leadership and Care Team's to which their geographies align.… more
- Merck & Co. (Rahway, NJ)
- …matters. Employee Relations works closely with other areas of the HR community, Compliance and Employment Legal in addition to managers to help facilitate a ... manager experience in a high performing team environmentExperience conducting investigations , developing and conducting manager trainingProject management experienceChange management… more
- Merck & Co. (Rahway, NJ)
- …manufacturing and GMP product testingExperience in leading and supporting quality investigations and change managementExperience with internal / external audit ... expertise as a subject matter expert for quality controlInteracting with internal and external partners to foster collaborations and actively contribute to… more
- Merck & Co. (Durham, NC)
- …meticulous attention to detail and possess good organization skills Assist in investigations , which includes interactions with vendors or internal teams to ... of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing process.Supervise manufacturing and manufacturing support activities for cGMP compliance through spot checks/ internal audits.Collaborate with site ... reagents.Strive to reduce non-conformances in supported areas by proactively driving compliance .Support Investigations team by providing quality and … more
- Merck & Co. (Rahway, NJ)
- …will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices (cGMPs), and participating ... in risk assessments, deviation investigations , and Good Documentation Practices (GDPs).-A high level of innovation, creativity, and self-initiative along with the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …assistance is available for selected candidate. Relationships Reports to: Manager, Investigations & Compliance Number of subordinates with direct/indirect ... in collaboration with NNUSBPI SME's & process groups Develops & maintains internal & external stakeholder relationships Ensures projects are completed with metrics &… more
- Merck & Co. (Rahway, NJ)
- …Familiarity with United States and European Union cGMP and Safety compliance regulations.Ability to prepare Risk Assessments, Standard Operating Procedures (SOP) and ... with large scale capital projects.Experience in leading and supporting quality investigations and change management.Experience with sterile drug product GMP facility… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …various subunits of the Quality System and ensuring accountability. Achieving compliance with cGMP and other relevant regulatory requirements and fostering ... Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the Quality… more
- Insmed Incorporated (San Diego, CA)
- …LIMS. Escalate out of trend observations and support associated investigations , including: temperature excursion assessments, client and regulatory requests, and ... Manufacturing and CMOs, Material Management, and other functions to ensure internal timelines, testing TAT, and team milestones are achieved.Create, maintain, and… more
- Merck & Co. (Rahway, NJ)
- …will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices (cGMPs), and participating ... in risk assessments, deviation investigations , and Good Documentation Practices (GDPs).-A high level of innovation, creativity, and self-initiative along with the… more
