- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations based on potential impact on product quality, patient safety , and regulatory compliance . Address recurring deviations and health authorities' ... myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based… more
- Eisai, Inc (Nutley, NJ)
- …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 ... profile, we want to hear from you. Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …To support workflow management and coordination of all daily operations of Product patient Safety 's case processing activities, which include the receipt, ... and quality tasks in order to ensure consistency and compliance in all activities performed by Patient Safety...for submission to the FDA Monitor the quality of Product patient Safety deliverables and provide ongoing… more
- Catalent (St. Petersburg, FL)
- Manager, QA ( Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control, Client interface, Lab Investigations, Deviations,… more
- Catalent (St. Petersburg, FL)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent ... Compliance ManagerPosition SummarySt. Petersburg is our primary softgel...aspects including but not limited to Quality Systems, Finished Product Batch Release, Training, Internal/External Audits, Complaints, APR, Investigations,… 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 ... has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides… more
- Tris Pharma (Monmouth Junction, NJ)
- …is responsible for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) ... agreements with appropriate business partners and assumes accountability in ensuring compliance with safety data exchange activities Reviews and/or contributes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …risk management tools and resources.Responsibilities- Strategic Advice and Support to Global Product Teams: 1) Provides expert, strategic advice on the creation and ... management sciences, and risk management tools and resources.- Risk Management Compliance Inspection Readiness Champion. Serve as member of Risk Management office… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …mindset and culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies. Provide quality ... with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in...for Distributors, co-partners, and affiliates. Liaise with Audit and Compliance team to ensure that GVP audits are planned,… more
- Merck & Co. (Durham, NC)
- … - Responsible for creating and sustaining a culture that ensures that compliance ( Safety , Environment, cGMP, etc.) are imperatives for the business.- ... role will contribute to the performance and results of a E2E drug substance/ product department and provide technical guidance. Off-shift and weekend coverage will be… more
- Merck & Co. (Durham, NC)
- …documents) to support project and ongoing operations. Identifies and addresses compliance , environmental, safety , and process deviations as appropriate while ... to troubleshoot and communicate appropriately and effectively Identifies and addresses compliance , environmental, safety , and process deviations as appropriate… more
- Catalent (Manassas, VA)
- …and requirements. Verifies and keeps records on incoming and outgoing product & material movements, accurately. Process daily, weekly cycle counts.Location: ... shipping documents ie BOL, packing list, pro-numbers. Assembles and inserts product into cardboard containers or selects pre-assembled containers; Posts weights and… more
- Eisai, Inc (Nutley, NJ)
- …in a dialogue about clinical evidence, approved indication(s), and the product efficacy/ safety profile to support on-label prescribing for appropriate ... the midst of an important launch of a new product in the US focused on educating HCPs on...cross-functionally while adhering to all of Eisai's ethics and compliance standards. Essential Functions Develop and maintain superior clinical… more
- Merck & Co. (Millsboro, DE)
- …charts, log books, and all pertinent documentation. Identifies and addresses compliance , environmental, safety , and process deviations as appropriate while ... 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 (Philadelphia, PA)
- …Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent ... management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA requirements. They will… more
- Catalent (Philadelphia, PA)
- …Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent ... approving batch records, and releasing batch records and finished product . They will have a deep understanding and values...a deep understanding and values around patient and employee safety , will assist in the enforcement of GMPs and… 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 ... and Reimbursement (PCOR) Account Management, the SME for Medical Review Committee, Compliance , Legal, Personal Promotion, and other HCP related policies. The role… more
- Aequor (Hicksville, OH)
- …Operational and Design Safety zero incidents in Projects and in operations Compliance with cGMP, HSE Audits etc. Cooperates with the other MS&T Key positions to ... Digital & Technology Savvy Operational Excellence Project Excellence Manufacturing Process/ Product Expertise Control Strategy and Process Performance Monitoring Knowledge… more
- Aequor (Hicksville, OH)
- …Operational and Design Safety zero incidents in Projects and in operations Compliance with cGMP, HSE Audits etc. Cooperates with the other MS&T Key positions to ... Digital & Technology Savvy Operational Excellence Project Excellence Manufacturing Process/ Product Expertise Control Strategy and Process Performance Monitoring Knowledge… more
- Merck & Co. (Rahway, NJ)
- …to lead and support facility operations, process development activities, compliance investigations/change management, authoring of GMP documentation, and lead other ... as needed. The position is also responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well as ensuring facility readiness… more
