- Actalent (Piscataway, NJ)
- Job Title: Quality Assurance and Regulatory Affairs SpecialistJob Description As a Quality Assurance and Regulatory Affairs Specialist, ... as a team, and transcending what is possible. + Support Regulatory Affairs and Quality Assurance management as needed. + Perform all other duties as… more
- Bayer (Whippany, NJ)
- …Product Development, as well as executives in Marketing, Sales, Manufacturing, Drug Safety, Quality Assurance , Regulatory Affairs and Legal Departments; ... identified and shared with key internal stakeholders; + Assists in any designated quality assurance review program. Ensures that information systems used by… more
- J&J Family of Companies (Raritan, NJ)
- …continuous improvement. **Stakeholder Collaboration:** + Work closely with cross-functional teams, including Quality Assurance , Regulatory Affairs , and ... compliance frameworks. **Data Management:** + Establish protocols for data integrity, quality assurance , and validation to support compliance objectives. +… more
- Stryker (Mahwah, NJ)
- We are currently seeking a **Senior Manager, Regulatory Affairs ** to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). Ideally, ... FL with some workplace flexibility. As the **Senior Manager, Regulatory Affairs ** , you will lead and...labeling, and marketing materials + Communicate and collaborate with Quality Assurance , R&D, Service, Global Supply, Finance,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **JOB SUMMARY** The Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to ... SM) and relevant external stakeholders. The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC and EU):in an efficient… more
- Veterans Affairs, Veterans Health Administration (New York, NY)
- …is integrated with other services' function. The incumbent performs process improvement, quality assurance and administrative functions as requested that are ... etc; specialized areas of a complex nature such as nuclear pharmacy, quality assurance , pharmacy informatics, clinical applications coordinator, Home Based… more
- Danaher Corporation (New York, NY)
- …to maintain labeling integrity. + Collaborate with internal stakeholders: Work closely with Regulatory Affairs , Quality Assurance , and Manufacturing ... and improve human health. This position is part of Quality Assurance and will be remote with...and procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs , and Marketing, to develop labeling… more
- System One (Florham Park, NJ)
- …electronic submissions. + Coordinate with cross-functional teams, including Regulatory Affairs , Clinical Development, and Quality Assurance , to obtain ... work collaboratively with cross-functional teams, including regulatory affairs , clinical operations, and quality assurance... regulatory affairs , clinical operations, and quality assurance in a team-oriented environment. +… more
- Citigroup (New York, NY)
- …of and help anticipate regulatory concerns. + Review and provide quality assurance of risk management deliverables submitted to regulators. + Support ... also provides opportunity to support the development of the new regulatory affairs model across the broader risk management team. **Qualifications:** + 10+… more
- Merck (Rahway, NJ)
- …Capabilities, Quality Assurance , Technical Operations, and CMC Regulatory Affairs , to address technical challenges, provide scientifically sound guidance ... field with 3 years of relevant experience in analytical development, validation, and/or quality control, or MS degree. **Experience and Skills** Required + At least… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in relevant training programs. + Provide mentorship and guidance to RD PV QA on quality assurance practices and regulatory compliance. + Keep abreast of ... and that technology-related audits are conducted. + Oversee and guide quality assurance processes related to project specifications, ensuring standard… more
- Sanofi Group (Morristown, NJ)
- …+ Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial to align ... that leverage digital technologies for advanced research opportunities. **Compliance and Quality Assurance ** + Accountable for ensuring all evidence generation… more
- American Express (New York, NY)
- …of and experience with enterprise / operational risk management processes including regulatory exam management / regulatory affairs , issues management, ... has a Professional Practices group responsible for managing audit operations, quality , and standards; regulatory relations; reporting; training and professional… more
- Wolters Kluwer (New York, NY)
- …processes and develop new processes. + Support external and internal audits; represent Quality Assurance as a subject matter expert. + Assure integration and ... device software launches and market expansions. **Post-Market Surveillance and Regulatory Affairs ** + Coordinate post-market activities including surveillance,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …, Pharmacovigilance, Health Economics & Outcomes Research, Generics, and Clinical Quality Assurance . + Develop, maintain and deliver communications and ... and experience working with Clinical and Pre-Clinical Research, Generics, Medical Affairs , Pharmacovigilance, Health Economics & Outcomes Research, Regulatory ,… more
- City of New York (New York, NY)
- …priority for the Agency. IHD's Engineering Services includes the Quality Assurance , Laboratory Services, Specifications/Standard Operating Procedures, ... to regularly modify and update the documents. The specification program is also responsible for quality assurance and quality control to ensure that in house… more
- City of New York (New York, NY)
- …teams involved in critical areas like drug-resistant TB case management and regulatory affairs . This position requires a highly organized, detail-oriented, and ... take clear and concise meeting minutes. - Assist the Regulatory Affairs Coordinator: Support the preparation and...the MDR-TB coordination team: Assist with data extraction and quality assurance checks; serve as a reliable… more
- Catalent Pharma Solutions (Somerset, NJ)
- …systems and sites. **EDUCATION AND** **EXPERIENCE** : Requires a Bachelor's degree in Drug Regulatory Affairs and 3 years of experience in job offered or 3 ... and IT teams acting as an expert on quality , regulatory , and compliance resource, bringing forth...new world-class systems and leverage existing systems for the assurance of GMP Manufacturing to help support the growth… more
- US Bank (New York, NY)
- …- Other is a management position that supports the Corporate Functions, Regulatory Reporting, and SOX Administration Audit Director. This role supports the Audit ... Director, in providing the Audit Committee and senior management with independent assurance and advisory services designed to evaluate and improve the effectiveness… more
- American Express (New York, NY)
- …high-risk areas signal need for intervention and focus), including conducting independent quality assurance and vertical process testing + Compile thematic risk ... improvements + Identifying areas of risk for intervention, including conducting independent quality assurance and process testing + Reviewing thematic risk… more