- BioAgilytix (Durham, NC)
- …BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, ... to ensure alignment on data goals and processes.Act as an advocate for data quality and governance , providing education to teams on the importance of … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Management Support Safety/ Quality /Training leadership in operational and governance meetings Lead cross-functional improvement projects with stakeholders ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...The Position The Patient Safety, Compliance & Operational Excellence Lead is responsible for driving efficiency, quality ,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a seasoned IT SAP Finance Director to lead the design, delivery and continuous improvement of SAP Finance solutions across our ... a large, distributed team. This role will own the roadmap and governance for Finance, Digital Payments, and SAP reporting/analytics platforms (BW/HANA), and will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of external data -- acceptance, storage, and delivery activities to ensure complete, high- quality data is available for use by clinical study teams in a ... continuous process improvements and other initiatives.Proactively identifies and manages risks to data quality , data integrity, programming and reporting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …potential suppliers, manage RFI/RFP and term sheet development, and negotiate contracts. Lead cross-functional teams and collaborate with Quality , Legal, CMC, ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Category Sourcing Lead as part of the Global Operations team based in Raritan, NJ. Role… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an approved cell therapy product in the Multiple Myeloma space including validation, data analytics and commercial support. The Quality Compliance scope includes ... functional partners.Key Responsibilities Integrate into appropriate sub-teams particularly validation, data analytics (including CPV), quality compliance (including… more
- Jazz Pharmaceuticals (Redwood City, CA)
- …assisting and/or leading audit and inspection processes and preparing for governance meetings to achieve compliance, inspection readiness, and continuous improvement ... Advise on deviations and change control management process. Partner with Quality , Regulatory Affairs, Regulatory Operations and CMC and Labeling organizations in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The position serves as the lead of Clinical Data Science & Evidence (CDSE) operations. In their role, they ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Millsboro, DE)
- …(freeze-drying) capacity being built at the site.This role is the Technical Lead for Lyophilization with both deep scientific experience and practical commercial ... manufacturing judgment. You will lead technical strategy, science-based technology transfer and scale-up of freeze-drying and fill-finish processes for vaccine and… more
- Merck & Co. (Rahway, NJ)
- …Matter Expert (SME) - Associate Director, will report to the Animal Health Global Quality Compliance and Technical Lead .-- The responsibility of this position is ... across all Animal Health operating units; however, the position will focus on US Quality activities related to governance by the USDA.-- The role will require… more
- Merck & Co. (Rahway, NJ)
- …commercial teams, supply chain, quality , IT, and external partners/vendors. Lead stakeholder engagement strategies, facilitation of governance forums, and ... Lead cross-functional delivery programs (software, controls, integrations, data /analytics, automation vendors), ensuring disciplined program governance and… more
- Formation Bio (New York, NY)
- …to align ingestion, orchestration, and governance frameworks with curation needs. Data Quality & Catalog Stewardship Enforce structural and semantic ... harmonizing, and unifying complex biomedical and healthcare data into high- quality , stakeholder-ready assets. You'll lead efforts to transform structured,… more
- Insmed Incorporated (NJ)
- …through Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including ... phase-appropriate quality system improvements for development-stage programs.Participate in Quality governance forums, providing expert input on GMP… more
- Cipla (Fall River, MA)
- …milestones and stage gate reviews. Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned ... About Cipla Cipla is a leading global pharmaceutical company, dedicated to high- quality , branded, and generic medicines. We are trusted by healthcare professionals… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including all vendor managed activities with the goal of achieving the highest data quality standards, full adherence to patient's rights and well-being and ... Data Management teams, MA stakeholders and CROs to ensure high data quality , proactively identifying and resolving issues throughout the clinical trial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with a focus on corporate functions (eg, Procurement; Real Estate; Digital, Data and IT; Finance and Tax) and complex and high-risk supplier contracting. ... IT, Clinical, Research, Operations, Patient Support Programs, and Digital Health Lead cross functional collaboration with internal colleagues, including those in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …upon study plans, properly identifying risks/mitigations, escalating as appropriate and utilizing data and metrics to put appropriate strategies and plans in place ... process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of the overall portfolio status and that any risks… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and monitor performance of vendors against service level and KPIs. Develop governance , business continuity, quality , and vendor monitoring plans. Maintain ... contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that are… more
- Merck & Co. (Rahway, NJ)
- …second generation process development and health authority licensure.- - You'll lead the charge in transforming our late-stage pipeline into reality bringing ... a culture of diversity, inclusion, and equity. Experience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed teams.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the main point of contact and support all signal management activities. They will lead the safety signal governance and develop, or update associated policies, ... of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to standardize, optimize, and...as instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool… more
