- Repligen (Waltham, MA)
- …of 10 years of experience in a cGMP, ISO 9001, or ISO 13485 Quality Management System environment required.Minimum 5-8 years of experience mentoring and ... OverviewWe are seeking an experienced Director of Quality candidate to lead...release including deviation support, root cause analysis, customer complaint management , hosting customer/regulatory audits and Certificate of Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal, epidemiological data, and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter ... a 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …has advanced skills in continuous improvement, project management , change management , and risk management . Responsibilities Leadership, Direction, and ... around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data...work.- Proactively identifies and manages risks for the data management function and supports functional risk identification/… more
- Merck & Co. (Rahway, NJ)
- …blisters) meet safety, efficacy, quality , and robust supply standards. Drive proactive risk management activities, including risk assessment, risk ... and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial ... Sr Director , Medical Affairs QA to conduct quality reviews of product profiles, ensuring thorough management...of the Quality Manual into an annual Quality Plan, including quality risk … more
- Merck & Co. (Rahway, NJ)
- …Contract Negotiations, Data Analytics, Driving Continuous Improvement, Negotiation, Outsourcing Management , Procurement, Risk Management , Strategic Sourcing, ... join our Professional Services Procurement team as an Associate Director . As a member of the Professional Services Team,...to, the optimization of the following: the Global Category Management Strategy, Contract, Risk and Stakeholder … more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment, risk ... thermal and distribution qualification for pharmaceutical products.Strong understanding of risk management principles.Strong strategic and analytical thinking,… more
- Merck & Co. (Rahway, NJ)
- …to the leader of Packaging and Combination Product Commercialization, the Director of Sterile Product Packaging Development is responsible and accountable for ... development activities from packaging design concept through launch, strategic management of the sterile development portfolio, and delivering on organizational… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE the Director… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to develop value-added ... proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies, device risk management , and design verification testing to develop value-added ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership...proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.Qualifications:Bachelor's degree in mechanical engineering,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study teamsDevelop best practices and lessons learned mechanisms within Clinical OperationsDevelop risk assessment & risk management and clinical project ... management competencies within Clinical OperationsWork in collaboration with Quality Management and Quality Assurance to develop and implement quality… more
- Merck & Co. (Durham, NC)
- …technical business processes including:- technical documentation, change control, portfolio management , risk mitigation, deviation management , technical ... is seeking a highly motivated individual for the role of Assoc. Director , Engineering.- This role will provide end-to-end support of manufacturing science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define and implement strategies ... rare diseases and immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the development and...will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the… more
- Merck & Co. (Durham, NC)
- …Global Science and Technology (GSEC) organization is seeking a highly motivated Director to lead our Pneumococcal Franchises (PCV) - Development and Commercial Team ... their product lifecycle-from development through commercialization and sustained supply. The Director will lead a team of specialists and collaborate across multiple… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operations management , tech transfer, process and equipment validation or quality management ; with a preference for Cell/Gene Therapy experienceMinimum of ... Strong financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management : Ability to identify, assess, and mitigate… more
- Merck & Co. (North Wales, PA)
- …tasks.Extensive experience with quantitative decision tools for root cause analysis, risk management and options analysis.Exhibited leadership qualities such as ... Equipment, Packaging Processes, Pharmaceutical Packaging, Process Optimization, Regulatory Requirements, Risk Management , Root Cause Analysis (RCA), Technical… more
- Insmed Incorporated (San Diego, CA)
- …Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the regulatory leader on ... regulatory representative on cross functional teamsCommunicating regulatory strategies and risk assessments to cross-functional teams and senior leadership, as… more
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management , and compliance in vendor agreements. Ability to work ... bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic… more
Related Job Searches:
Director,
Director Quality,
Director Quality Management,
Director Quality Risk,
Director Risk,
Director Risk Management,
Management,
Quality,
Risk,
Risk Management