- Catalent (Manassas, VA)
- …Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent ... to help create engaging new products consumers will love.The Procurement Manager is responsible for procurement leadership, sourcing and procuring materials,… more
- Merck & Co. (Durham, NC)
- …own unit. Compliance - Creating and sustaining a culture that ensures that compliance ( Safety , Environment, cGMP, etc.) are imperatives for the business - ... the team finishes the design and construction of the facility, the Operations Manager will play a critical role in supporting the Global Engineering Services team,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate ... writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Take responsibility to ensure meeting logistics,...in accordance with DS standards. Act as the project manager of the clinical study team to liaise and… more
- Catalent (Harman, WV)
- The Manager , Supply Chain - Warehouse , reporting to the Director, Supply Chain, has an opportunity to make a significant impact on the way that the Harman's site ... operates. The Manager , Supply Chain - Warehouse will lead a shift...with other functional leads to improve operational performance and compliance will be a success factor for this role.This… more
- Catalent (TX)
- Job Description Manager , Contract Management The Manager , Contract Management serves as a strategic business partner to our Business Development and Legal ... organizations. The Manager , Contract Management will support the development and execution of contracts with new and existing customers ensuring Catalent has strong,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study ... or non-interventional research studies (including Post Authorization studies), in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... ensure business objectives are met Manages and monitors organizational compliance with all established supplier agreements Provides strategic procurement… more
- Insmed Incorporated (San Diego, CA)
- …within scope of training including routine preventive maintenance, calibration, and safety checks. Oversees and reviews area weekly and monthly Quality Control ... QC database. Set up and validate new assays as assigned by the manager .ResponsibilitiesManage and direct work responsibilities for team as well as prioritize tasks… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to prioritize investigations based on potential impact on product quality, patient safety , and regulatory compliance . Address recurring deviations and health ... myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality support across programs ensuring GCP, GPV, GDP, and adherence to safety requirements are adequately considered for all Medical Affairs programs. Interact ... with legal and compliance as required. Proactively collaborate with other GxP quality...Investigator initiated studies and Collaborative Research.Support adherence to regulatory safety requirements for all programs (ie post marketing, MAA… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...and evaluates quality processes and system standards to ensure compliance with applicable Janssen standards, industry standards, and global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... area including functional representatives, corporate representative, IT, privacy, legal, compliance , IT security, etc.Responsibilities- In conjunction with the Director… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the preparation of ... analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure… more
- Catalent (St. Petersburg, FL)
- …environment within the manufacturing area by overseeing and ensuring compliance with current Good Manufacturing Practices and Standard Operating Procedures ... the QA Specialists. The role is responsible for actively identifying compliance enhancements/improvements and leading project to deliver solutions. Furthermore, this… more
- Novo Nordisk Inc. (Durham, NC)
- …in accordance with relevant project plans & timelines. Relationships Senior Manager , Quality Control - OFP. Essential Functions Accuracy & Scientific Soundness ... of Lab Data Environmental Compliance GMP Compliance of Laboratory Maintain testing...& Investigations Analysis of Samples Supports Deviations Follow all safety and environmental requirements in the performance of duties… more
- Merck & Co. (Durham, NC)
- …of new systems which enhances the operation and/or engineering processes. Quality & Safety Compliance : The successful candidate should be able to examine an ... by policies, procedures and business plan; receives guidance from manager . Contributes to the performance and results of the...issue from diverse perspectives ( safety , compliance , automation, equipment, process, and people)… more
- Merck & Co. (Durham, NC)
- …safe maintenance and repair of equipment using Hazardous Energy Control Procedures. Compliance with current good manufacturing procedures(cGMP), safety and ... guided by policies, procedures and business plan; receives guidance from manager .Manage multiple priorities and advance several tasks in parallel.Must be flexible… more
- Merck & Co. (Durham, NC)
- …for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.-Responsible for ... establishing processes that ensure required safety guidelines are followed.-Review and approve qualification/validation documents for equipment and process (ie,… more
