- 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 ... you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers...including FDA and ICH regulations and guideline Expertise in safety databases and quality systems Knowledge of… 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)
- …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....a strategic leader for the role of GxP Patient Safety , Compliance & Vendor Oversight within our Clinical, Medical… 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 ... to proactively identify and mitigate potential issues Compliance & Quality Assurance Partner with NNI Patient Safety ...& Quality Assurance Partner with NNI Patient Safety Management to ensure timely and accurate processing of… more
- Merck & Co. (Rahway, NJ)
- …as needed. The position is also responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well as ensuring facility readiness ... pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the...compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific… 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 divisional ... 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 Leadership and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... methodologies, tools, and core deliverables. Relationships Reports to the Director , Sales Reporting & Forecasting. Position regularly interacts with members… 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...(especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both ... investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic reporting. Serves as the key DSI contact for PV… more
- Merck & Co. (Rahway, NJ)
- …Ensure that all activities are conducted with the highest regard for safety , quality , and regulatory compliance, aligning with the company's divisional ... Job DescriptionJob Summary: The Director , Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization.… more
- Merck & Co. (Rahway, NJ)
- …systems.Ensure that all activities are conducted with the highest regard for safety , quality , and regulatory compliance, aligning with the company's divisional ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership role within the Device Development and Technology Organization. This… more
- Tris Pharma (Monmouth Junction, NJ)
- …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
- 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 ... Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE the Director… 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 ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , Engineering as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe Associate Director of Engineering is a strategic and operational leader...equipment, and systems support business goals and comply with safety , regulatory, and sustainability standards. This position is a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director ... 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. (Durham, NC)
- …supply of commercialized products for the benefit of patients. The Associate Director of Equipment Engineering is integral to this mission. The successful candidate ... competency, equipment validation & qualification, Lean Manufacturing/Six Sigma, GMP, Safety Standards, Project mgmt., Preventive & Predictive maintenance, Serialization,… 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...key stakeholders across R&D, clinical, regulatory, marketing, manufacturing, and quality functions.Educate and build awareness of HF principles to… more
- Merck & Co. (Rahway, NJ)
- …and ensure that all platforms (eg syringes, auto injectors, bottles, blisters) meet safety , efficacy, quality , and robust supply standards. Drive proactive risk ... Job DescriptionDir, Engineering - Director , Assembly and Packaging Platform Technical LeadershipReporting into the Executive Director Packaging Technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily ... and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best… more
