- 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
- Merck (West Point, PA)
- …with batch disposition (release) activities. + Background in quality control, quality assurance , auditing or regulatory affairs. + Effectiveness and creativity ... compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around… 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
- 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
- J&J Family of Companies (New Brunswick, NJ)
- …United States of America **Job Description:** Johnson & Johnson Global Audit & Assurance (GAA) organization is seeking a Senior Technology Auditor. The preferred ... location for this position is New Brunswick, NJ. Global Audit & Assurance 's primary mission is to provide independent, objective assurance and advisory services… more
- Integra LifeSciences (Plainsboro, NJ)
- …patient outcomes and set new standards of care. **SUMMARY DESCRIPTION** The Senior Manufacturing Engineer will play a key role in driving manufacturing excellence, ... They will collaborate with cross-functional teams, including R&D, Quality Assurance , and Operations, to optimize manufacturing processes, troubleshoot technical… 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
- Lumen (Trenton, NJ)
- …manager to bolster and drive our compliance programs. Reporting to the Senior Director Security for GRC and Business Enablement, the information Security Governance ... our external and internal obligations. This role will be expected to provide guidance and make determinations relevant on controls that govern the steps, methods, or… more
- Prime Therapeutics (Trenton, NJ)
- …It fuels our passion and drives every decision we make. **Job Posting Title** Senior Internal Auditor - Remote **Job Description** The Senior Internal Auditor ... fostering strong cross-functional relationships and delivering risk-based insights, the Senior Internal Auditor helps drive informed decision-making and support… 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
- Deloitte (Princeton, NJ)
- …with a well-respected team of proven innovators! Work you'll do: As a Senior , you will identify eligible federal C&I generating activities and manage and facilitate ... member firms - Tax, Advisory, Consulting, and Audit and Assurance . The ideal candidate is invested in the team's...process improvements and opportunities for new services. The Tax Senior will ensure accurate, timely completion of deliverables. The… more
- Edwards Lifesciences (Trenton, NJ)
- …with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize ... and be part of our inspiring journey. As the ** Senior Specialist, Commercial Clinical Imaging** , you will be...and other imaging modality acquisition and interpretation and provide guidance on case planning strategy execution. + Responsible for… 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
- 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
- J&J Family of Companies (New Brunswick, NJ)
- …States of America **Job Description:** Johnson & Johnson Global Audit & Assurance (GAA) organization is seeking a Lead Technology Auditor! The preferred location ... this position is New Brunswick, NJ. Global Audit & Assurance 's primary mission is to provide independent, objective ...Lead a team of auditors during audit engagements providing guidance , delegation, and feedback + Provide leadership and coaching… 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