- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position is ... quality system integrity expected by the customer. The Quality Director is committed to relentlessly pursuing...will oversee the health of the manufacturing processes through risk monitoring and oversee the conformance to the QMS… more
- Merck & Co. (Rahway, NJ)
- …and 10 years overall within biopharmaceuticals. Planning and facilitating high risk and highly complex Quality -related process reviews and/or investigations ... Job DescriptionThe incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of innovation across… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global Engineering Solutions (GES), the Associate Director ... of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case development through… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to a Technology Director in Global Engineering Solutions (GES), the Associate Director will be part of a high performing team, ... of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case development through… more
- Genmab (Plainsboro, NJ)
- …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 ... skills and knowledge on process management & improvement, strategic & risk management planning, change management and stakeholder management. Leading and supporting… 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)
- …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 ... difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide...based on current regulatory environment and competitive landscape Assess risk and advise on mitigation strategies to meet overall… 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 ... to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance. Proactively track, monitor and report trial risks,… 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 ... capabilities and will be responsible for planning, coordinating, and executing timely and high- quality submissions to the FDA.This is a hybrid position based in our… more
- Merck & Co. (Rahway, NJ)
- …tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with ... and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead cross-functional… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including: communication, planning and management of schedule, budget, scope, issue risk management, and quality /outcomes. Communication: Ensure that assigned ... the 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading to successful approval of ... for synergies between the products. When goals are tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue… more
- Merck & Co. (Rahway, NJ)
- …teams to evolve the technical landscape toward the desired end state.- Apply risk -based decision making to complex problems and consult with relevant subject matter ... 15%.- Strong Information Management Background Skills in MDM, Data Quality , Information Governance, Data Modelling, Information Architecture and Metadata… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …PV regulations for individual case safety reporting, periodic reporting and risk management. Develops and implements strategic initiatives for global process ... deriving from these contracts. Organize and conduct periodic review of contract quality and adherence. Support business functions in determining PV relevance for… more
- Merck & Co. (Rahway, NJ)
- …Clinical Supply Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines,- strategies ... needed Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio… more
- Merck & Co. (Rahway, NJ)
- …service activities to ensure supply continuity that meets our quality , compliance, and regulatory standards.Strategic collaboration with Procurement and finance ... executional excellence focusData Driven decision making with experience in risk based decision makingDemonstrated ability to motivate and influence with… more
- Merck & Co. (Rahway, NJ)
- …maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across Global Regulatory Affairs and ... Safety , including training process standards and strategies to ensure optimal quality and compliance in Global Regulatory Affairs and Clinical Safety business… more
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