- Catalent (St. Petersburg, FL)
- …to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management ... Compliance ManagerPosition SummarySt. Petersburg is our primary softgel...Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and ... for and assures follow up of adverse event reports that potentially impact the safety profile of product area responsibility. Interacts with staff at other Eisai and… more
- Merck & Co. (Rahway, NJ)
- … - Accountable for creating and sustaining a culture that ensures that compliance ( Safety , Environment, cGMP, etc.) are imperatives for the business. Accountable ... Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the 24-hour… more
- Merck & Co. (Durham, NC)
- …safety issues and completing corrective/preventative actionsDrive culture of compliance through actions, consistent quality-driven decision making, and coaching ... Job DescriptionThe role of Operations Manager at our Company's Durham facility is a...provide area/process overview information to visitors/auditors upon requestQuality & Safety ComplianceFoster strong and effective safety culture… 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)
- …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
- 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 ... help create engaging new products consumers will love.The Site Procurement Manager is responsible for procurement leadership, sourcing and procuring materials,… 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
- 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 (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's ... Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides customer service, with the highest integrity, focused on quality… 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
- Novo Nordisk Inc. (Durham, NC)
- …& DK based) & external stakeholders Drive a safe workplace culture, ensuring safety & environmental requirements are met Maintain plans to meet changes in customer ... to meet quality specifications & requirements, to include GMP Compliance of the team Ensure appropriate support is on...implementation of cLEAN® principles in the team Follow all safety and environmental requirements in the performance of duties… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and Preventive Actions (CAPA) process, and is responsible for ensuring compliance within quality systems processes. Key Responsibilities Lead the CAPA program ... continuous improvement of quality systems processes. Implement processes to ensure compliance with current Good Manufacturing Practices (cGMP). Manage multiple and… more
- BioAgilytix (Durham, NC)
- …life-changing, life-saving therapeutics to the patients who need them.The Archive Manager is responsible for the management, operation, and procedures related to ... retrieve the appropriate documents, explain the archive procedures, and verify compliance with established procedures Establish processes and procedures for managing… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide ... of skilled technical experts to design, develop and implement Adobe Experience Manager (AEM) solutions that support digital transformation efforts and meet the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study, ... of the trial.Performs clinical study site management/monitoring activities in compliance with ICH-GCP,-Sponsor SOPs, Local Laws & Regulations, Protocol, Site… more
- Merck & Co. (Durham, NC)
- …a comprehensive technology transfer of the HPV vaccine manufacturing process while ensuring compliance with all regulatory and safety guidelines. Lead a diverse ... people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the… more
- Catalent (Harman, WV)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent ... and eight additional suites coming online.Reporting to the Vice President and General Manager , the Senior Director Supply Chain directs all facets of supply chain… more
