- Insmed Incorporated (NJ)
- …providing quality oversight of GxP computerized systems throughout their lifecycle, ensuring compliance with FDA, EMA, and ICH regulatory requirements. This role ... systems across their lifecycle (implementation, operation, maintenance, and retirement) to ensure compliance with FDA, ICH, and EU regulations. Review and approve… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline ... AAV, lentiviral, gene editing, cell-based therapeutics), a strong understanding of regulatory requirements, and the ability to work cross-functionally in a… more
- Jobleads-US (Long Beach, CA)
- …and regulatory developments to keep policies current and ensure compliance . . Drive change management initiatives related to performance management, partnering ... Overview Assistant Director of HR (Employee Relations and Compliance ) Location Long Beach, CA Department Unit Human...the primary point of contact for external audits and regulatory inquiries, ensuring timely, accurate, and compliant responses. .… more
- Jobleads-US (Portland, OR)
- … regulatory developments to keep policies current and ensure compliance . Drive change management initiatives related to performance management, partnering closely ... Overview Assistant Director of HR (Employee Relations and Compliance ) Location Portland, OR Department Unit Human Resources Job Code 8130 At Novogradac, we value… more
- Merck & Co. (Durham, NC)
- …and Preventive Action (CAPA), Critical Thinking, Detail-Oriented, Documentation Review , Driving Continuous Improvement, Environmental Monitoring, GMP Compliance ... with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Insmed Incorporated (NJ)
- …toxicology through Phase 3. This role ensures phase-appropriate GMP compliance across manufacturing development, while providing strategic Quality leadership across ... is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines.What You'll Do: Provide strategic and… more
- Insmed Incorporated (NJ)
- …deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs and ... Collaborates with cross-functional team members within Biometrics, Clinical Operations, Regulatory , and Clinical Development, as well as with external vendors.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... the quality and timely delivery of programming deliverables, including integrated data review plan (IDRP), study data listings and exception reports, sample data… more
- Insmed Incorporated (NJ)
- … compliance with eTMF documentation and audit readiness activitiesSupport regulatory filings (IND/CTA/IMPD), act as SME during inspections, perform risk ... strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and continuous improvement reviewsEstablish and maintain KPIs,… more
