- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure that deliverables are met according to agreed timelines and quality standards . Lead a team of professionals specializing in intelligent automation, ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Formation Bio (New York, NY)
- …and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for Formation Bio's portfolio. Acting ... and vendor oversight. The Sr. Director ensures compliance with cGMP standards , oversees QA activities at CDMOs, performs critical documentation reviews, and… more
- Formation Bio (New York, NY)
- …and more efficiently.About the PositionWe are seeking a seasoned Staff Engineer to lead our AI Foundations Team-a new initiative dedicated to establishing the core ... ecosystem, we'd love to hear from you. ResponsibilitiesArchitectural Leadership: Define and lead the end-to-end design of our AI Platform, ensuring robust, scalable,… more
- Formation Bio (New York, NY)
- …of quality systems to ensure adherence to regulatory requirements, industry standards , and best practices in pharmaceutical manufacturing and defending it during ... (QMS) to ensure compliance with regulatory requirements (eg, FDA, EMA), industry standards (eg, cGMP), and company policies. Establish and maintain quality assurance… more
- Formation Bio (New York, NY)
- …efficiency and increase the probability of success.Responsibilities Strategic Leadership: Lead and develop the Biostatistics team, fostering a high-performance ... to improve efficiency, quality control, and compliance with industry standards . Data-Driven Decision-Making: Champion data-driven approaches and quantitative decision-making… more
- Formation Bio (New York, NY)
- …requirements. Ensure that clinical trials are conducted to the highest quality standards , with a focus on patient safety, data integrity, and regulatory compliance. ... guidelines. Strong strategic thinking and analytical skills. Proven ability to lead and develop high-performing teams in a fast-paced, dynamic environment. Strong… more
- Merck & Co. (Rahway, NJ)
- …device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position ... applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies...the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead … more
- Merck & Co. (Rahway, NJ)
- …DescriptionJob Description Are you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination ... including inhalation, implantation, and injection.The Associate Principal Scientist will lead the definition and execution of design verification strategies, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Merck & Co. (Rahway, NJ)
- …state-of-the-art technology and applying rigorous scientific and ethical standards .-The Distinguished Scientist (Executive Director) and Product Development Team ... (PDT) Lead , Oncology Global Clinical Development, has primary responsibility for...the field of Thoracic Oncology .The Executive Director, PDT Lead will manage the entire cycle of clinical development,… more
- Merck & Co. (Rahway, NJ)
- …work in accordance to applicable regulatory requirements, guidelines, and industry standards as well as update regulatory changes and communicate relevant updates ... to ensure compliance with electronic submission formats and global regulatory standards , and identifies opportunities to enhance efficiency and streamline regulatory… more
- Merck & Co. (Rahway, NJ)
- …and Plant) within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles and models that ... for GMP manufacturing processes, secure networks compliant with ISA/IEC 62443 standards .Be the SME for our Shop Floor Network (Manufacturing division Core… more
- Merck & Co. (Rahway, NJ)
- …regulations to support a compliant workplace.Develop and manage company's safety standards and technical guidelines to ensure compliance and reduction in workplace ... safety risks. Lead global continuous improvement initiatives to improve global safety...operations.Being a change agent to ensure all changes to standards , guidelines, systems and tools achieve the desired outcome.Partner… more
- Merck & Co. (Rahway, NJ)
- …with a mix of remote and on-site work. Key Responsibilities: Lead cyber security incidents and perform investigation, containment, and remediation efforts.Provide ... and recommend rules and other process changes.Create, review, and update standards , baselines, standard operations procedures, and runbooks for the function,… more
- Merck & Co. (Rahway, NJ)
- …as well as developing and enhancing solutions over time.Perform as a Team Lead who is hands-on and utilize demonstrated experience in developing and maintaining the ... and Monitoring, that entails: Partner with IT to Define data governance standards and build business / technical lineage with Collibra; Define Business Terms… more
- Merck & Co. (Rahway, NJ)
- …development, as well as for commercialization and in line commercial projects. Lead development and implementation of robust non-GMP characterization methods, using ... Experience & Skills: Expertise in authoring regulatory guidance and quality standards , authoring and reviewing of regulatory submissions and responses (IND and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are responsible for the delivery… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path… more
