- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal stakeholders to proactively identify and mitigate potential issues Compliance & Quality Assurance Partner with NNI Patient Safety Management to ensure ... are consistently met Implement Medical Review Prospective & Retrospective Quality Review of cases Regulatory Intel &...including FDA and ICH regulations and guideline Expertise in safety databases and quality systems Knowledge of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the GxP Compliance & Technical Operations. This job will interact with Patient Safety , Quality , Vendor and Contract Management, IT, Finance, Contract/Supplier of ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....and track training completion rates to ensure compliance with safety and regulatory requirements Lead the development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …is responsible for driving efficiency, quality , and innovation across US Quality , GxP Compliance Training and Patient Safety Operations. This role ensures ... Functions Operational Excellence & Process Improvement Lead initiatives to streamline Safety / Quality /Training processes Apply Lean Six Sigma or other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Safety , and centralized teams (eg, Training and Documentation, Quality , Supplier and Contract Management and Digital Enablement). This role will provide ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...to proactively identify and mitigate potential issues Compliance & Quality Assurance Partner with NNI Patient Safety … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordinate and manage available resources in developing and delivering high- quality safety evaluation related documents/deliverables on time.Coordinate and ... rare diseases and immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the...regulatory , but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of… more
- Post Holdings Inc. (New Albany, OH)
- …and supply chain leadership to provide support and solutions for situations involving Quality , Food safety and regulatory Compliance + Develop Strategic ... the Manufacturing plants and Distribution network. As a QFSE Director you will partner with Operations leaders to ensure...the systems, processes and capabilities involved in management of quality , Food Safety and Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high ... fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director 's Medical Affairs … more
- Merck & Co. (Rahway, NJ)
- … Assurance: Ensure that all activities are conducted with the highest regard for safety , quality , and regulatory compliance, aligning with the company's ... Job DescriptionJob Summary: The Director , Combination Product Commercialization is a key leadership...launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:… more
- Merck & Co. (Rahway, NJ)
- …delivery systems.Ensure that all activities are conducted with the highest regard for safety , quality , and regulatory compliance, aligning with the company's ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership...launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Utilize… more
- Merck & Co. (Rahway, NJ)
- … Assurance:Ensure that all activities are conducted with the highest regard for safety , quality , and regulatory compliance, aligning with the company's ... Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role...launch in alignment with the company's business goals, and quality and regulatory compliance.Essential Duties and Responsibilities:Program… more
- BWX Technologies, Inc. (Oak Ridge, TN)
- …and Safety (EHS) to lead the development and execution of world-class regulatory compliance, safety , licensing, and quality programs for our advanced ... regulatory success, and a deeply embedded culture of safety and accountability. **Location** On-site in Oak Ridge, TN...Oak Ridge, TN **Your Day to Day as the Director of Environmental Health and Safety (EHS):**… more
- Merck & Co. (Rahway, NJ)
- …that all solutions (eg thermal containers, package designs, new components) meet safety , efficacy, quality , and robust supply standards. Develop and maintain ... relationships with internal stakeholders, including supply chain, packaging commercialization, quality , analytical, regulatory , manufacturing, Device Development and… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical ... signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and...depending on the program / portfolio being led. The Director , Safety Scientist provides key support as… more
- Merck & Co. (Rahway, NJ)
- …packaging & device development and technology teams, supply chain, operations, quality , analytical, regulatory , and project leaders. The successful candidate ... and ensure that all platforms (eg syringes, auto injectors, bottles, blisters) meet safety , efficacy, quality , and robust supply standards. Drive proactive risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance, promote ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Merck & Co. (Rahway, NJ)
- …with cross-functional teams and stakeholders to ensure that all platforms meet safety , efficacy, quality , and robust supply standards. Develop and maintain ... strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory , manufacturing, and Supply Chain to facilitate… more
- Tris Pharma (Monmouth Junction, NJ)
- …to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety , quality , and regulatory standards in warehouse operationsManages, ... in our Monmouth Junction, NJ facility for an experienced, hands-on SR. Director / Director , Procurement. Title and salary commensurate with experience. The … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence: Oversees the Management of ... Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …campus infrastructure, equipment, and systems support business goals and comply with safety , regulatory , and sustainability standards. This position is a key ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , Engineering as part of the Technical Operations team based in… more
- Merck & Co. (Rahway, NJ)
- …and post-market activities-ensuring integration of HF principles to enhance patient safety and product usability. The Senior Director will champion ... Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary...the HF team and key stakeholders across R&D, clinical, regulatory , marketing, manufacturing, and quality functions.Educate and… more
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