- Merck & Co. (North Wales, PA)
- …preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation.Interact independently with ... seamless communication and establishing robust procedures, we ensure swift, organized compliance with global regulatory agencies. As an international network… more
- Insmed Incorporated (San Diego, CA)
- … of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality ... Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director… more
- Repligen (Waltham, MA)
- …- Quality Network Leader, Chromatography & Proteins.ResponsibilitiesThe Director , Quality will be responsible for:Maintaining site compliance to ISO 9001 ... OverviewWe are seeking an experienced Director of Quality candidate to lead...as host for site auditsMaintain risk-based strategy for overall Quality compliance across the organization and in… more
- Eisai, Inc (Nutley, NJ)
- …and make a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance ... office. Eisai Salary Transparency Language:The base salary range for the Director , Clinical Quality Assurance is from :195,000-256,000Under current guidelines,… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... ( our Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Twist BioScience (South San Francisco, CA)
- …continuous improvement, technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the ... MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance, and R&D. The Director will serve as the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Eisai, Inc (Exton, PA)
- …well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics ... close-out of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also… more
- Tris Pharma (Monmouth Junction, NJ)
- …inventory control systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality , and regulatory standards in ... negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory … more
- Merck & Co. (Rahway, NJ)
- …controls approach within Device Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and ... Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T)… more
- Merck & Co. (Rahway, NJ)
- …Operational Strategies, Outsourcing, Process Improvements, Production Scheduling, Project Management Planning, Quality Compliance , Regulatory Compliance ... establish boundaries and ground rules for engagement with the EPs, while ensuring compliance / quality readiness of these suppliers at all times through the… more
- Merck & Co. (Durham, NC)
- …Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization ... compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control).-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (San Diego, CA)
- …transfers and mentoring junior staff. Maintaining laboratory equipment, ensuring safety and regulatory compliance , and supporting audits are also part of the ... for trend analysis are also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with ... pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in shaping… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic ... procurement policies, procedures, and governance frameworks to ensure consistency, compliance , and cost discipline. Collaborate with finance, legal, R&D, and… more
- Eisai, Inc (Nutley, NJ)
- …and provide input into CME budget and website portal as needed. Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical ... your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the...industry, and to ensure compliance with Eisai policies & procedures.Provide support for new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision ... within R&D. Reviews and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees and is accountable… more
- Twist BioScience (South San Francisco, CA)
- …partnerships, maximizing their impact on business goals. Compliance & Quality :Ensure all activities comply with applicable regulatory standards including ... Twist Bioscience is seeking a strategic and execution-oriented Director or Senior Director of Business Development (title commensurate with experience) to lead… more
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