- Merck & Co. (Rahway, NJ)
- …Team.-This Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs CMC ( Global Regulatory Affairs & ... and limited CMC post-approval-changes.Leverage industry and agency connections in partnership with Regulatory Affairs Global Regulatory Policy and the Head… more
- Insmed Incorporated (NJ)
- …understanding of US, EU, and Japanese regulations for human drugs/biologics.Knowledge of global regulatory guidance documents and regulations with emphasis on ... of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible...and life cycle management, and ensure they meet current regulatory standards, are of high quality , consistent,… more
- Merck & Co. (Millsboro, DE)
- …leaders and frontline teams, and who works effectively across functional partners. Quality - and compliance-focused with practical experience supporting regulatory ... Integrated Process Team that directly influences site performance, product quality and cost-of-goods for life-changing animal vaccines. Your leadership will… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs ... future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the...Regulatory Affairs, lead the development and implementation of global regulatory strategy plans to facilitate efficient… more
- Capital One Bank (Newport News, VA)
- Director , Payment Network Technology RiskCapital One is one of the fastest growing organizations in the world today, powered by our passion for our customers. We are ... innovation through technology, we equally prioritize cybersecurity, reliability, software quality , and data management. Technology & Data Risk Management (TDRM)… more
- Eisai, Inc (Nutley, NJ)
- …(QAP) position is responsible for design, delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection ... potential. Essential Functions Direct and drive design, delivery, and execution of the global Clinical Quality Assurance (CQA) strategy for the country/region in… more
- Merck & Co. (North Wales, PA)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... include:Function as Business System Owner (BSO) of the current Documentum-based global submission content management solutionCo-lead the implementation of the next… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high ... Sr. Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive quality excellence through effective business partnerships… more
- Insmed Incorporated (NJ)
- … governance forums, providing expert input on GMP requirements and ensuring alignment with global Quality strategy.Lead and develop a team of 2-8 Quality ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Management to ensure safety information is processed according to corporate timelines, quality and regulatory requirements Leads the safety follow-up process ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Quality Control will be responsible for leading and overseeing all ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...release, stability, and in-process testing in accordance with cGMP, regulatory requirements, and company quality standards. The… more
- Merck & Co. (Rahway, NJ)
- …and coach to the HF team and key stakeholders across R&D, clinical, regulatory , marketing, manufacturing, and quality functions.Educate and build awareness of HF ... Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary...growing HF teams in a regulated environment.Deep knowledge of global HF regulatory requirements, FDA guidance, and… more
- Merck & Co. (Rahway, NJ)
- … quality , and supply chain.- Proven ability to lead global , cross-functional teams through complex strategy/ project development and execution. Knowledge ... of business functions including Technology, Manufacturing Operations, Finance, Regulatory , Quality , Compliance, Supply Chain and Commercial. Understanding of… more
- Insmed Incorporated (San Diego, CA)
- …for the future of science, we're in. Are you?About the Role:Reporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of... Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs,… more
- Eisai, Inc (Durham, NC)
- …and make a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance ... activities. Eisai Salary Transparency Language:The base salary range for the Director , Clinical Quality Assurance is from :195,000-256,000Under current… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and ... optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance,… more
- Merck & Co. (Rahway, NJ)
- …all levels of the organization - Demonstrated knowledge of current US, and global Regulations, ICH guidance, ISO standards, and quality system regulations for ... Job DescriptionThe Associate Director , Engineering, Packaging Commercialization will lead packaging development...execution of overall packaging strate g ies that meet global network needs. Responsibilities include ensuring packaging system design… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data Management) sets the ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to ... regulatory , but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define… more
- Insmed Incorporated (San Diego, CA)
- …Standards.Data Quality & Compliance: Ensure EDC systems comply with regulatory requirements (eg, FDA, EMA, ICH-GCP) and company SOPs.Perform user acceptance ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...of science, we're in. Are you?About the Role:The Associate Director , EDC Programming will lead and oversee EDC programming,… more
