- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical ... across regions and functional areas. The role of the Global Process Lead involves developing and maintaining efficient, effective, and compliant business standards,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Merck & Co. (North Wales, PA)
- …or post-market commercial manufacturing vaccines and biologics. - Technical scope: Lead the hands-on execution of upstream pilot-scale experiments. Typical unit ... operations include shake flasks, wave rockers, 50 - 500L...(eg, statistical process control (SPC) and/or multivariate analyses (MVA). Lead technical investigations and process changes that drive improvements… more
- Merck & Co. (Rahway, NJ)
- …Description: The Office of General Counsel is seeking an Associate Director, Trademark Operations to provide docketing and legal operations support to the ... Property (IP) organization. Primary responsibilities are to oversee the Trademark Operations team, including operations and workflow; partner with the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Warehouse Operations Manager as part of the Technical Operations team based in ... Role OverviewThe Warehouse Operations Manager will work within Technical Operations and be responsible for the ongoing site ramp-up, daily operational… more
- Merck & Co. (North Wales, PA)
- …of our medicines and vaccines. As the Associate Director of Launch Strategy and Operations , you will play a vital role in preparing for and accelerating the growth ... focused on introducing new launch capabilities while refining existing launch operations and processes. You will collaborate with cross-functional teams across the… more
- Merck & Co. (Millsboro, DE)
- …a Bio-Technology Center of Excellence that performs vaccine production operations from antigen production through formulation, filling and packaging.-With expertise ... revise processes and procedures against corporate and regulatory requirements to insure compliance Review production records for completeness and compliance to… more
- Merck & Co. (North Wales, PA)
- …role is a key leadership position, accountable to identify, prioritize, and lead key strategic initiatives that support the US Vaccines franchise. The person ... in this role will be responsible for leading the on-going tactical operations of the franchise including facilitation of key meetings, oversight and strategic pull… more
- Merck & Co. (North Wales, PA)
- …for delivery of recruitment and retention strategies and tactics in compliance with federal and local country regulations. (25%)Project management of Recruitment ... They will represent GTO, with support from GO TA lead , at cross functional review meetings such as LDRC/EDRC...or other applicable legally protected characteristics. - For more information about personal rights under the US Equal Opportunity… more
- Genmab (Plainsboro, NJ)
- … Information Security will report directly to the VP and Global Head of Information Security and IT Risk & Compliance , playing a strategic role in the ... is essential to fulfilling our purpose.Job Description - Director, Digital Assets, Information SecurityPosition Summary: The Director Information Security is a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality ... the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from...and post-inspection-related activities under the supervision of the IMT Lead .Management Review: Collect the data and information … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Support Programs, Patient Safety, Quality, NNI IT and Telephony, Medical Information , Compliance , Regulatory, Legal and Privacy. External relationships include ... and other safety information related to Novo Nordisk products and in compliance with Novo Nordisk and FDA requirements Understands PSP operations , including… more
- Merck & Co. (Durham, NC)
- …site.-- The successful candidate will report to the Associate Director, Laboratory Operations to lead start-up new laboratories for microbiological testing and ... and Decision Making:Represents Quality in the laboratory to influence cGMP compliance and ensure product qualityExplains information and persuades others… more
- Merck & Co. (Lower Gwynedd, PA)
- …Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce) Vaccines bioanalytical group ... Gwynedd Township, PA.We are seeking a talented, organized, and innovative leader to lead our Laboratory Operations and System Validation team. The successful… more
- Merck & Co. (Rahway, NJ)
- …Director of Compliance , reporting to the Senior Director of GMP Operations , will oversee laboratory compliance across multiple sites, managing regulatory ... compliance in an analytical laboratory.Extensive experience in technical operations , including resource modeling and capacity planning.Expertise in analytical… more
- Merck & Co. (North Wales, PA)
- …for Product Manager - PV Case Intake and Processing. Reporting into Product Line Lead Patient Safety and Quality & Compliance , this position will be responsible ... solutions that help everyone to be more productive and enable innovation.The Information Technology team at our Company's R&D division (our Research & Development… more
- Genmab (Plainsboro, NJ)
- …drug supply.Maintain agreements, contracts, and SOPs to support efficient operations .Forecast demand, manage inventory, and prevent stockouts. Lead ... in partnership with several internal and external stakeholders, including GCDS Operations , GCDS Systems, Development Operations , Portfolio & Project Management,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking an Asset Reliability Engineer as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Asset / Reliability Engineer will ... deployed and maintained following necessary GMP requirements. This person will be the lead for equipment optimizations as well as system upgrades with the systems… more
- Merck & Co. (Baton Rouge, LA)
- …leadership and implementation of troubleshooting activities and change control.Initiate and lead collaboration within the Operations , Quality and Technical ... administration, documentation updates, data querying, operator training, day to day operations support. T he Automation Senior Specialist will work closely with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …practices.Develop positive relationships with the QA team, Quality Control, Information Technology, maintenance, Manufacturing personnel, Technical Operations ... to meet business objectives.Support Investigations team by providing quality and compliance input for continuous improvement; and remediation's. Lead continuous… more
