- 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
- Integra LifeSciences (Princeton, NJ)
- …manufacturing. **Cross-Functional Collaboration:** + Collaborate closely with cross-functional teams (eg, quality assurance , regulatory affairs , R&D, ... projects, and work cross-functionally. + Detail-oriented with a commitment to maintaining high- quality standards and regulatory compliance. + Experience with … 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
- 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
- J&J Family of Companies (Titusville, NJ)
- …regulatory filings. Team matrix interactions include project management, finance, legal, quality assurance , quality monitoring & compliance, clinical ... supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical affairs , clinical pharmacology, clinical… 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
- J&J Family of Companies (Titusville, NJ)
- …Clinical Team. Team matrix interactions may include project management, finance, legal, quality assurance , quality monitoring & compliance, clinical supplies ... unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics,...team and be responsible for timely completion, content and quality of key documents eg clinical development plans, protocol… 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