- Highmark Health (Trenton, NJ)
- …team of specialists. Identify, develop, coordinate, and implement legislative, regulatory , sub- regulatory , and licensing / accreditation requirements.Perform ... ongoing monitoring and analysis of external regulatory and industry intelligence, collaborating with impacted stakeholders, and providing regular, executive… more
- Lilly (Branchburg, NJ)
- …external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance , current expectations and business needs. This role also aids ... world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity...the other sites. + Benchmark industry trends and emerging regulatory guidance / requirements in the field… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Edwards Lifesciences (Trenton, NJ)
- …and documentation of product complaints, including reporting of events to regulatory Agencies. Provide Medical/Clinical Guidance to Complaint Staff and ... us and be part of our inspiring journey. The Senior Manager, Clinical Product Quality will plan and lead...**How you will make an impact:** + Provide medical/clinical guidance to complaint staff and engineers related to event… more
- Integra LifeSciences (Princeton, NJ)
- …**Cross-Functional Collaboration:** + Work closely with R&D, manufacturing, quality assurance , and regulatory teams to ensure sterilization processes ... new standards of care. **SUMMARY** We are seeking a highly skilled and motivated Senior Process Engineer II with a focus on sterilization processes in the medical… more
- Integra LifeSciences (Princeton, NJ)
- …Collaboration:** + Collaborate closely with cross-functional teams (eg, quality assurance , regulatory affairs, R&D, production) to ensure contamination ... standards of care. **SUMMARY** We are seeking a highly skilled and motivated Senior Process Engineer II a focus on manufacturing contamination control in the medical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …programs. + Provide mentorship and guidance to RD PV QA on quality assurance practices and regulatory compliance. + Keep abreast of evolving regulations and ... and implement proactive strategies to address data integrity issues identified during regulatory inspections, such as those from Quality Events, Audits Findings and … more
- J&J Family of Companies (Titusville, NJ)
- …**POSITION SUMMARY:** The incumbent will serve as a Senior Director, Clinical Leader in Neurodegeneration, Neuroscience, with a ... Team matrix interactions may include project management, finance, legal, quality assurance , quality monitoring & compliance, clinical supplies unit, TA strategy, … more
- Sokol Materials & Services (Skillman, NJ)
- CQV Engineer Senior Level Job Location Skillman, NJ Workspace On-site position (no remote or hybrid options) Target Hiring Date TBD Work Authorization Applicants ... qualification. + Strong understanding of validation principles, methodologies, and regulatory requirements, including FDA, EMA, and ICH guidelines. Knowledge, Skills… more
- Integra LifeSciences (Princeton, NJ)
- …new standards of care. **SUMMARY** We are seeking a highly skilled and motivated Senior Process Engineer II with a focus on bacterial endotoxin testing programs in ... to ensuring product safety and compliance. The candidate must be a senior -level professional/team player with advanced process engineering knowledge and a propensity… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …development and continuous improvement of these processes across GxPs. Provide guidance and support eQCMS (TrackWise or similar system) enhancements in collaboration ... with Global Quality Systems. Provide guidance and perform a risk assessment for global CAPA...Experience and Skills: **Required:** + 6+ years of Quality Assurance experience in the Pharmaceutical (Drug/Biologics), Drug Device Combination… more
- Cardinal Health (Trenton, NJ)
- …on those requirements. + Uphold quality standards that adhere to company, regulatory , and HIPAA policies and procedures. + Collaborate across various functions, ... skills with a proven ability to develop and execute effective quality assurance programs. + Works independently within established procedures; may receive general … more
- BeOne Medicines (Pennington, NJ)
- …collaboration with the CMC, Process Development, Manufacturing, Quality Control, Quality Assurance and Regulatory groups. This position requires advanced ... Effective communication with team members and stakeholders. + Provide oversight and guidance for technology transfers. + Drive tech transfer schedule commitments. +… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Manager, HR Project Office - Project Manager position has a focus on ... Serve as a project management subject matter expert, providing guidance to project teams and across HR. + Stay...+ Stay up-to-date with industry trends, best practices, and regulatory changes to ensure HR compliance and effectiveness. **Change… more
- Bausch + Lomb (Trenton, NJ)
- …B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance , Pharmacovigilance/GPSS and Drug/Device ... completion of clinical studies according to applicable regulations and guidance , ICH and GCP, and Bausch & Lomb SOPs...are being met and provide the operations director and/or senior management with timely updates on progress and changes… more
- Sokol Materials & Services (Skillman, NJ)
- …to coordinate and execute CQV activities. * Review validation documentation under the guidance of senior team members, ensuring compliance with ALCOA+ principles ... and workshops to advance skills in validation and quality assurance . * Stay updated on regulatory guidelines,...and quality assurance . * Stay updated on regulatory guidelines, industry trends, and best practices in validation.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **JOB SUMMARY** The Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA ... develop risk mitigation strategies. Provide comprehensive quality oversight and strategic quality guidance /advice to the MA functions located in the Americas and EU… more
- Prime Therapeutics (Trenton, NJ)
- …Enterprise Architect - Cloud Transformation - Remote **Job Description** The Senior Principal Architect is responsible for initiating and leading strategic solutions ... and information), shared infrastructure services and shared application services. The Senior Principal Architect leads the analysis and design tasks to support… more
- City National Bank (Trenton, NJ)
- …written and verbal communication skills * Keep up to date with relevant regulatory guidance , industry practices and Bank policies by attending outside forums ... and third party support services ensuring compliance with bank policy and regulatory compliance * Facilitate service delivery meetings to ensure delivery against… more
- BeOne Medicines (Pennington, NJ)
- …cycle times, on time closure dates, and QA objectives, whilst adhering to regulatory compliance and achieving business success. Work to support both internal GMP ... QA and Compliance SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being 'fit for purpose'...impacts the business and communicating any changes to the Senior Management Team. + Ensuring that the QA batch… more