- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing ... resource planning for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Market Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs, Integrated Customer Engagement, Global and other relevant NNI ... key therapeutic area opinion leaders, and organizations as well as professional service vendors. This role will oversee the portfolio strategy team with members… more
- Twist BioScience (South San Francisco, CA)
- …an experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation , and optimization of our ... continuous improvement, technical excellence, robust software development practices, and regulatory compliance.Software Development & Implementation : Oversee the… more
- Insmed Incorporated (San Diego, CA)
- …a Receiving Unit (internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations ... act as a Process Development Team representative as an Analytical Lead for a drug program.Key Responsibilities:Responsibilities include developing and optimizing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the ... and QMS records.Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This individual is responsible for the training of Manufacturing… more
- Eisai, Inc (Nutley, NJ)
- …buy and bill, GPO distribution and hospital P&T, landscape of infusion service reimbursement is preferred.Experience in development and implementation of brand ... want to hear from you. The Director, HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle planning projects focused on the… more
- Merck & Co. (Durham, NC)
- …Calibration Engineer is a member of the Engineering, Maintenance and Site Services (EMSS) team providing support to the Durham sites.- This includes Energy ... This position will focus on maintaining the calibration program, including implementation of new instruments for calibration, investigation into instrument events… more
- BioAgilytix (San Diego, CA)
- …and evaluating results. Identify new analytical techniques and technologies and lead their implementation .Review analytical instrument and equipment calibration, ... Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …metrology job plans and associated master plansParticipates in the development, implementation and sustainment of emergency response programs and other safety ... and collaborating with key stakeholders and functionsActively participates in all regulatory and internal audits of the facilityPartner and manage relationships with… more
- Merck & Co. (Durham, NC)
- …Specialist, Calibration is a member of the Engineering, Maintenance and Site Services (EMSS) team providing support to the Durham sites.- This includes Energy ... This position will focus on maintaining the calibration program, including implementation of new instruments for calibration, investigation into instrument events… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Enterprise Insights, Supply Chain, Procurement, Public Affairs, Public Policy, Regulatory , Legal, IT, Trade, Patient Safety and Compliance. External relationships ... status meetings, monthly reporting and calibration calls Leads development and implementation of programs to ensure seamless and consistent patient experience across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk US Operations, including ED&AA, IT, Ethics and Compliance, Commercial, Patient Services , CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk ... AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI...tasked with providing strategy and vision on the technical implementation , optimization, and deployment of AI/ML pipelines, AI/GenAI models… more
- Eisai, Inc (Exton, PA)
- …groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics ... review for phase III and PV at CMOs at the company's discretion.5. Lead and assist in troubleshooting upstream and downstream process, product, and equipment issues… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …realize your potential? The Position Responsible for the design and implementation of manufacturing processes, instrumentation, and equipment start-ups from the ... this role will be commensurate with experience. Relationships Reports to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process and… more
- USAA (Phoenix, AZ)
- …processes and programs while balancing operational efficiency, competitiveness, and regulatory compliance. Implementation may include overseeing business ... to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the #1 choice for the… more
- USAA (Phoenix, AZ)
- …to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the #1 choice for the ... USAA, where our core values honesty, integrity, loyalty and service define how we treat each other and our...us special and impactful. The Opportunity The Data Scientist Lead will work closely with the Data Science Director… more
- Boston Scientific (Maple Grove, MN)
- …determine the regulatory impact Develops and maintains positive relationships with regulatory agency staff Lead and/or participate in regulatory audits, ... both verbally and in writing Demonstrated ability to develop strong relationships with regulatory agency staff Demonstrated ability to effectively lead multiple … more
- Abbott (Maple Grove, MN)
- …is to combine the knowledge of Regulatory , Quality and Compliance to lead and assist implementation projects for emerging regulations and supporting quality ... Regulatory Quality Senior Specialist position would be structured under the Global Regulatory Services (GRS) function managing projects related to harmonized … more
- Mattel (El Segundo, CA)
- …all our brands, partners, and suppliers. The Team: The Global Quality, Safety, Regulatory Compliance, Governance & Risk, Consumer Services , and Sustainability & ... this role will work with SMEs across the GQSRCSSI team (eg, regulatory reporting, climate, circularity, human rights, data analytics, compliance, etc.) and other… more
- Actalent (Chicago, IL)
- …Auditor The AS9100 Lead Auditor is responsible for leading the implementation , maintenance, and continuous improvement of the Quality Management System (QMS) in ... culture of quality and operational excellence. Responsibilities: Oversee the development, implementation , and maintenance of the QMS in accordance with AS9100… more
