- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Director , Quality Management Systems plays a pivotal role in ensuring ... indicators (KPIs), and dashboards to monitor the QMS's performance and drive continuous improvement . In collaboration with GXP Quality Leads, ensure the timely… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and ... release, stability programs, change management, and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at CDMOs,… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Trial Management is responsible for leading and overseeing ... time, and in compliance with all regulatory requirements. The Director will manage a team of Clinical Trial Managers...Ensure that clinical trials are conducted to the highest quality standards, with a focus on patient safety, data… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionAs Director , Product Design at Formation Bio, your primary focus will be translating ... and stakeholders Develop and implement best practices for Design productivity, quality , and cross-functional collaboration People Lead the Product Design team in… more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and ... has strong ownership & accountability of assigned work - Drive continuous improvement initiatives to enhance the efficiency, accuracy, and effectiveness of clinical… more
- Merck & Co. (Rahway, NJ)
- …CSS team with IS&O initiatives and daily operations, adopting high- quality change practices and embodying our Companys Enterprise Leadership Skills.Stakeholder ... to understand business requirements and drive cost reduction efforts.Continuous Improvement : Contribute to operational performance by assisting in setting objectives… more
- Merck & Co. (Rahway, NJ)
- …real estate and workplace solutions aligned with corporate strategy.The Associate Director of Real Estate Strategic Planning will play a crucial leadership ... team, promoting best practices in strategic planning and data management.Continuous Improvement : Identify and implement process improvements within the real estate… more
- Merck & Co. (Rahway, NJ)
- …DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development Team designs, ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… more
- Merck & Co. (Rahway, NJ)
- …for traceability / lineage and make them available for business consumption; Monitor data quality report and work proactively with IT on data issues as part of daily ... complex or unusual business problems; and ability to facilitate continuous improvement efforts collaboratively with team and peers.Proficiency in using Programming… more
- Merck & Co. (Rahway, NJ)
- …to identify risks (ie when/how will the device fail?) and opportunities for improvement . They will utilize a wide variety of cutting-edge analytical instruments and ... with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, EU MDR,… more
- Merck & Co. (Rahway, NJ)
- …to identify risks (ie when/how will the device fail?) and opportunities for improvement . In this role, the successful candidate will utilize a wide variety of ... with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, EU MDR,… more
- Merck & Co. (Rahway, NJ)
- …Responsibilities include, but are not limited to: Work closely with the group Director to shape and execute strategy for biological characterization in all stages of ... development and implementation of robust non-GMP characterization methods, using quality by design principles and with focus on comprehensive life-cycle… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process, define strategies to lead to the development and implementation of quality improvement initiatives across the organization.This role will focus on ... around rare diseases and immune disorders. JOB SUMMARYThe Associate Director , GMP QA Process Excellence is accountable to collect...as change agent to promote a culture of continuous improvement and quality awareness. Design, deliver and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary The Global Oncology Medical Affairs (GOMA) Director , Program Management & Operational Excellence provides strategic planning and ... operational management oversight of GOMA projects, activities, and budgets.The Director , Program Management & Operational Excellence is responsible for supporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and influences internal management and study level stakeholders on risk-based quality management principles, process improvement , metrics design and application ... responsible for implementation and oversight of the Risk Based Quality Management (RBQM) principles that support the Company's vision...improvement initiatives related to RBQM CSM to improve quality and ensure patient safety and data quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and support materials for end-users, handling of queries, troubleshooting, and quality control.Lead or support consulting and implementation projects in the area ... formats, correct inaccuracies, and validate the cleansed data against defined quality metrics.Implement and manage robust data governance processes to ensure ongoing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior ... and/or Tech Unit milestones. Continuously seek opportunities for the improvement in daily work (incl. alternative approaches) and respectively propose/implement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require ... primary accountability for operational study level time, cost and quality deliverables.Lead the development of the clinical study plan...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and oversight of the group. This position reports to the Associate Director Data Management Operations. Business administration activities within the CDR system may ... and maintaining new SOPs, Work instructions, templates, and other quality documents.Responsibilities:Leadership, Direction, and Strategy: Establish and manage accountability… more
