- Aequor (New Brunswick, NJ)
- …and Inventory Process Excellence team to support inventory forecasting process.Proactively support internal control compliance across the CTDO organization, ... . Prepare/review reconciliations and test related controls where appropriate.Support internal audits and SOX compliance testing of CTDO plants/processes, … more
- Merck & Co. (Rahway, NJ)
- … team in audits (provide input regarding origin requirements and internal processes and assist identifying findings); Lead prior/voluntary disclosure efforts ... Compliance , Global Initiatives, Human Resource Information Systems (HRIS), Internal Processes, International Trade Finance, IS Audit, Marketing Compliance ,… more
- Merck & Co. (Rahway, NJ)
- …Development (AR&D) Associate Principal Scientist to serve as a Device Analytical Lead supporting medical device and combination product (MDCP) programs at various ... sub-team within the Combination Product Working Group. -The Device Analytical Lead will partner closely with cross-functional teams, including device development and… more
- Eisai, Inc (Exton, PA)
- …maintains a repository of controlled documents related to GxP Systems Quality Assurance. Internal and External Auditing and Compliance Management: Responsible as ... Eisai is choosing, deploying and supporting computing platforms and solutions in compliance with applicable global regulations and in accordance with Eisai standards… more
- Merck & Co. (Rahway, NJ)
- …experience in medical devices or combination products Experience in design controls , ISO 13485, deviation management, change control , risk management/ISO ... Controls , Detail-Oriented, Deviation Management, Driving Continuous Improvement, Ethical Compliance , GMP Documentation, Injection Moldings, ISO 13485 Medical Devices,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …objectives. Qualification team will consist of managing external resources and some internal resources.Ensure safety, quality, and compliance is the main goal ... the qualification activities are performed within an appropriate level of GxP compliance . This individual will need to build strong partnerships with Engineering and… more
- Repligen (Waltham, MA)
- …expert on global payroll compliance .Design, implement, and maintain effective internal controls over global payroll in accordance with SOX(Section 404) ... OverviewThe Director, Global Payroll will lead the development and execution of Repligen's global...tosupport a growing global workforce. This role ensures proper controls and payroll compliance across jurisdictions,promotes operational… more
- Merck & Co. (Rahway, NJ)
- …reputation through conference participation.Represent BPR&D as a upstream bioprocess expert/co- leader in internal and cross-functional project teams.Supervise, ... medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAbout the Role:-As a Technical Lead , you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a ... mitigate risks, and continuously enhance performance. Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.… more
- Merck & Co. (North Wales, PA)
- …Data Management ( RDM) Strategy & Regulatory Data Standards Governance- - Regulatory Compliance and Risk Management for Regulatory Data - Direct and Indirect (eg, ... eg XEVMPD, IDMP, PQCMC, SPL etc . )- - Internal & External Stakeholder Engagement and Change Management for...enable f uture proofing of regulatory submissions and ensuring compliance with evolving standards beyond 2025 ( ie IDMP… more
- Merck & Co. (Durham, NC)
- …Position Overview : Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our ... establishing a strong business partnership and ensuring excellence in Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director,… more
- Novo Nordisk Inc. (Durham, NC)
- …also be responsible for the production activities & validation. Ensuring relevant compliance issues are addressed & handled in close collaboration with production. ... include review of batch reports & release of incoming materials, deviations, change controls , review & approval of SOPs, QA presence & process confirmation on shop… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal ... Job DescriptionWe are seeking a strategic and technical leader with expertise in cell culture development &...timelines, in a rapidly changing environment.Experience and aptitude to lead , work, and collaborate in internal and… more
- Merck & Co. (Rahway, NJ)
- …on tight timelines, in a rapidly changing environment.Experience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed ... development including cell banks, process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Scientists and Engineers support internal development and internal /external manufacturing operations to remain operational, continuously ... development including cell banks, process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation,… more
- Eisai, Inc (Exton, PA)
- …with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control , Validation, and other internal (PST) and external functions ... of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also responsible to… more
- Eisai, Inc (Raleigh, NC)
- …will lead a cross-functional team driving excellence in Import/Export Compliance , Logistics, and Supply Chain support while interfacing closely with other EDCS ... will lead a cross-functional team driving excellence in Import/Export Compliance , Logistics, and Supply Chain support while interfacing closely with other EDCS… more
- Merck & Co. (Rahway, NJ)
- …studies.The Associate Principal Scientist is the primary clinical study team leader and has overall responsibility for a study.The Associate Principal Scientist ... Protocol Ensure the timely selection and ordering of study materials. Ensure compliance of administrative aspects of the study (budgets and agreements) with the… more
- Aequor (Tampa, FL)
- …Assume temporary leadership responsibilities in the absence of Maintenance Team Leader Participate in internal /external training to support personal development ... and decommissioning. Develops and performs; work orders, work permits, change controls , and writes, reviews and/or approves Standard Operating Procedures (SOPs),… more
- Merck & Co. (Rahway, NJ)
- …program-level GCS point of contact representing the GCS Planning organization to customers both internal and external to GCS and serves as the lead GCS ... not limited to:--Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory, quality… more
