- Integra LifeSciences (Plainsboro, NJ)
- …new treatment pathways to advance patient outcomes and set new standards of care. The ** Lead Quality Inspector** serves as a Lead Associate, Quality ... using electronic document storage. + Minimum of 5+ years' experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably… more
- Integra LifeSciences (Princeton, NJ)
- …design, statistical analysis, process validation, regulatory compliance, clinical trials, computer systems validation, quality systems and/or data security. ... and set new standards of care. **SUMMARY** The Senior Quality Compliance Manager will lead , coordinate and...efficiency and efficacy of the corporate audit processes and systems whilst retaining the same levels of quality… more
- BeOne Medicines (Pennington, NJ)
- …+ Directly support operations with troubleshooting and issue resolution with respect to site quality systems . + Lead small cross functional teams in support ... Functions of the Job:** + Serve as the GTS Lead for Computer Systems Validation/Computer System Assurance...environment including gowning. + Collaborate and work closely with Quality systems teams at other sites. **Qualifications:**… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …sites, internal GMP (Good Manufacturing Practices) departments, external partners, and quality systems for ensuring compliance with regulatory requirements and ... You will be responsible for conducting thorough assessments of potential vendors' quality systems , capabilities, and processes to ensure alignment with… more
- Integra LifeSciences (Plainsboro, NJ)
- …All processing is performed in compliance with Good Manufacturing Practices (GMP), Quality Systems Regulations), Standard Operating Procedures (SOP's) and Health ... procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP's), and… more
- Integra LifeSciences (Plainsboro, NJ)
- …All processing is performed in compliance with Good Manufacturing Practices (GMP), Quality Systems Regulations (QSR), Standard Operating Procedures (SOP's) and ... procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations (QSR), Standard Operating Procedures (SOP's),… more
- Integra LifeSciences (Plainsboro, NJ)
- …compliance with ISO 7 Clean Rooms and with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP's), and Health and ... for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality of our medical devices. This includes assigning and monitoring daily 2nd… more
- Integra LifeSciences (Plainsboro, NJ)
- …7 and ISO 5 Clean Rooms and with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP's), and Health and Safety ... for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality of our medical devices. This includes assigning and monitoring weekend (Friday… more
- Integra LifeSciences (Princeton, NJ)
- …management. Develop negotiation strategies, gain alignment from stakeholders, lead cross-functional, category-based negotiation teams, and implement appropriate ... + Supplier Relationship Management: Interacts with stakeholders to develop, engage, and lead supplier relationships for extracting the greatest value in supplier … more
- BeOne Medicines (Pennington, NJ)
- …laboratory daily workflow. + Establish and maintain QC Physicochemistry laboratory related quality systems to ensure conformance with regulations and BeOne ... **General Description:** Manages all Quality Control (QC) Physicochemistry laboratory activities to support...Global quality standards. + Manage QC Physicochemistry laboratory routine operations,… more
- Parexel (Trenton, NJ)
- …responsible for site start-up, activation, relationship management, recruitment, and quality assurance. This role also contributes to site selection, provides ... issues, and collaborates with various functions to optimize communication, maintain site quality and patient safety utilizing data analytics to identify and mitigate… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …labels, shippers, displays). + Experience with cGMP's, all applicable FDA guidelines and Quality Systems . Prefer additional understanding of ISO, USP, ISTA, ASTM ... options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …products. Supported by more than 40 manufacturing facilities, we provide high- quality medicines, trusted by healthcare professionals and patients, to more than ... closely with key stakeholders including, but not limited to DEA, Operations, and Quality in coordinating the daily functions of the security department to ensure… more
- Parexel (Trenton, NJ)
- **Job Title:** Data Management Lead (Medical Affairs) - Oncology **Location:** Fully Remote (US based) Must be able to accommodate West Coast hours. **About Us:** At ... We are seeking a dynamic and experienced Data Management Lead to join our team. If you have a...practices for data collection, propose innovative solutions, and ensure high- quality , compliant data. + Use surveillance tools to review… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …equipment issues promptly. + Revise methods and procedures to improve efficiency and quality . + Utilize systems such as **SAP, TrackWise, EDMS, and ... products** . Supported by more than 40 manufacturing facilities, we provide high- quality medicines trusted by healthcare professionals and patients in over 100… more
- Terumo Medical Corporation (Somerset, NJ)
- …and applicable regulatory requirements, while driving continuous improvement in clinical quality systems and processes. Key responsibilities include planning and ... Sr. Clinical Quality Specialist Date: Dec 18, 2025 Req ID:...is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the… more
- Parexel (Trenton, NJ)
- …the world, ensuring innovative products are supported by clear, compliant, and high- quality documentation that enables safe and effective use across global markets? ... is seeking an experienced and highly motivated **Global Regulatory Labeling Lead ** to provide strategic leadership and operational oversight for complex global… more
- Parexel (Trenton, NJ)
- …and mock statistical output to determine appropriateness of content/format for clinical writing. ** Quality Control** + Ensure that all work is complete and of high ... quality prior to team distribution or shipment to client....Project Management** + Act in the capacity of project manager/ lead for medical writing projects, which may entail serving… more
- Parexel (Trenton, NJ)
- …clinical research. The Senior Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of ... of all relevant input. + Manage ongoing and/or revised project documentation and correspondence. ** Quality Control** + Ensure that all work is complete and of high … more
- Parexel (Trenton, NJ)
- …and KPIs + Knowledge and experience with clinical databases, electronic data capture systems , quality control processes, and auditing procedures + Proficiency in ... and industry collaborations in central monitoring capabilities. + Collaborate on Study Quality Risk Assessment: Participate in the development and refinement of the… more
