- Exela Pharma Sciences, LLC (Lenoir, NC)
- …for the Quality Management System deployed throughout the company. The Quality Director will oversee the health of the manufacturing processes through ... audits and management review. In addition, the Quality Director will represent the company as...21 CFR part 4, and all associated regulatory requirements.Drive risk management in design, validation, and ongoing… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part of our Global ... submission strategy for the compound. You must have strong project management capabilities and will be responsible for planning, coordinating, and executing… more
- Merck & Co. (Rahway, NJ)
- …in the clinical supply chain. The role oversees the budget status, expense management and financial analytics needed to ensure accurate control and forecast.The role ... attraction, development and retentionPerformance managementEnsures Efficient and compliant inventory management E2E processesDefines best strategies for sourcing any material… more
- Merck & Co. (Rahway, NJ)
- …Technical Operations,-Single Use Technology, or Sterile Operations.Strong project and time management skills to facilitate on-time delivery and quality ... of containment philosophies for potent compoundsExperience with Process Safety Management , Industrial Hygiene/Potent Compounds and Ergonomic Risk Assessment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global PV regulations for individual case safety reporting, periodic reporting and risk management . Develops and implements strategic initiatives for global ... around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication, planning and management of schedule, budget, scope, issue risk management , and quality /outcomes. Communication: Ensure that assigned ... initiative is on track and adheres to the strategic goals. Issue and Risk management and reporting: Ensure that assigned PMs identify and manage issues and risks… more
- Merck & Co. (Rahway, NJ)
- …Development. -The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Genmab (Plainsboro, NJ)
- …their skills and knowledge on process management & improvement, strategic & risk management planning, change management and stakeholder management . ... is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global Clinical Drug Supply… more
- Merck & Co. (Rahway, NJ)
- …Lab Lead will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and ... participating in risk assessments, and Good Documentation Practices (GDPs).-In addition to...and academic or industrial partnerships.- In partnership with the Director of Chemical Engineering R&D, the Crystallization Lab Lead… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …conduct is completed in compliance and meets Novo Nordisk's business standards Risk Management : Assessing and mitigating risks associated with operations, ... a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder Management : Build strong internal and external… more
- Merck & Co. (Rahway, NJ)
- …& connectivity between functions supporting pipeline (ie clinical development, Compound Management Coordination , supply chain, & human health), and balancing needs ... Clinical Supply Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines,- strategies… more
- Merck & Co. (Rahway, NJ)
- …and maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across Global Regulatory Affairs ... Safety , including training process standards and strategies to ensure optimal quality and compliance in Global Regulatory Affairs and Clinical Safety business… more
- Merck & Co. (Lower Gwynedd, PA)
- …Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce) ... and enable late-stage clinical trials through the generation of timely, high- quality regulated bioanalytical data. A combination of molecular (eg, PCR), serology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions ... smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical ... projects to ensure homogeneity within IT and supports oversight and management of integrations solution design, implementation strategy and requirements gathering,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all Strategic Sourcing efforts through to final contract, including project management , supply analysis, supplier identification, risk mitigation, sourcing ... Global) for given commodities/business areas and leading the overall supplier relationship management program for DSI, for DS products and alliances. Cultivates a… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...The successful candidate will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build… more
