- BeOne Medicines (Pennington, NJ)
- …+ Minimum of 8 years of experience in quality assurance and/or quality control in an FDA -regulated biotechnology or pharmaceutical company with progressive ... some travel. **_Essential Functions of the job_** **_:_** + Within the Quality Assurance organization, develop and implement Compliance programs for the Hopewell, NJ… more
- Robert Half Finance & Accounting (Bridgewater, NJ)
- …a dependable candidate with 3+ years of experience within the food production Quality Control field that has managed staff before. This a great opportunity to ... continue your career in Quality Control with a rapidly growing organization. Key Responsibilities:...plant laboratory and sanitation operations, including staffing, training, and regulatory compliance. + Analyze monthly consumer complaint data and… more
- Integra LifeSciences (Plainsboro, NJ)
- …Medical Device Directives, Canadian Medical Device Regulations, and other applicable regulatory agencies. Experience with assessing quality suppliers and ... patient outcomes and set new standards of care. The ** Quality Compliance Specialist** will provide quality compliance...and internal Standard Operating Procedures + Provide support in FDA inspections, ISO audits and customer audits at the… more
- BeOne Medicines (Pennington, NJ)
- …resolving complex production related issues. + Familiarity with EMA and FDA regulatory requirements for process development submissions. **Other ... and production operations at various scales. + Familiarity with EMA and FDA regulatory requirements for process development submissions. **Travel:** + Some… more
- Integra LifeSciences (Plainsboro, NJ)
- …pathways to advance patient outcomes and set new standards of care. The ** Quality Control Inspector Supervisor** will be overseeing the quality control ... inspection activities to ensure the safety, efficacy, and quality of the company's medical devices. This role is expected to provide technical and supervisory… more
- Bayer (NJ)
- …timely and accurate implementation of new and revised labeling in accordance with FDA requirements and provides regulatory expertise and guidance for labeling ... operations and strategy to deliver high quality submission labeling. The position also facilitates strategic development of labeling by leading cross-functional… more
- Sumitomo Pharma (Trenton, NJ)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... teams. Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and… more
- Bristol Myers Squibb (Princeton, NJ)
- …and optimize product benefit-risk profiles. The ED works cross-functionally with clinical, regulatory , medical affairs, quality , and commercial teams to support ... key leadership role ensures that pharmacovigilance (PV) activities align with regulatory requirements and company standards, and drives the strategy and execution… more
- J&J Family of Companies (Raritan, NJ)
- …ensuring in-stream data quality from partners. + Work with colleagues in Regulatory Affairs to ensure that all relevant regulatory documents (eg IDEs, PMAs, ... and clinical requirements for diagnostics development and commercialization, including global regulatory frameworks (eg, FDA , EMEA, PMDA). + Proven ability to… more
- J&J Family of Companies (Titusville, NJ)
- …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, global medical...team and be responsible for timely completion, content and quality of key documents eg clinical development plans, protocol… more