- Novo Nordisk Inc. (Plainsboro, NJ)
- …Trains vendor teams on new processes, develops process documentation and quality control documentation of data acquisition and support channels as needed ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …visualizations, external data acquisition and validation, and tools to support project portfolio across drug programs. This role is responsible for ensuring the ... for use by clinical study teams in a timely manner.Provides oversight for external data validation and quality control process for verification of the data… more
- ValSource, Inc. (Rahway, NJ)
- …ValSource is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a ... ensuring compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface with clients, lead teams of… more
- Merck & Co. (Rahway, NJ)
- …to work in a fast-paced job that provides a high degree of technical, project , and people management responsibility. - This SSO Facility Lead role within ... and breadth of scientific, technical, and operational experience to lead and support facility operations, process development activities, compliance… more
- Merck & Co. (Rahway, NJ)
- …benefits realization Lead cross-functional delivery programs (software, controls , integrations, data /analytics, automation vendors), ensuring disciplined ... controls ; translate shopfloor realities into robust digital and control solutions. Drive architecture-level decisions and integration approaches across MES/MOM,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and oversee all engineering management including asset/reliability, data systems/automation and Commissioning/Qualification.Support the development and ... environment.Strong knowledge of building systems (HVAC, electrical, plumbing), construction project management, and sustainability practices.Proven experience managing large capital… more
- Terumo Medical Corporation (Somerset, NJ)
- …knowledge of SAP security concepts, including authorizations, roles, and data access control . + Ability to lead critical issues involving SAP on GCP, Fiori ... security policies, procedures, and configurations to protect sensitive access, data and comply with various regulatory requirements (eg GxP,...the SAP S/4HANA. + Design and implement GRC Access Control . + Assist project manager in security… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our ... 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)
- …Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to standardize, optimize, and innovate signal ... contact and support all signal management activities. They will lead the safety signal governance and develop, or update...maintenance of signal tool and support tasks of change control , training material update, and end user support or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CAPA Management Process for the respective business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality execution across Medical ... monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process… more
- Merck & Co. (Rahway, NJ)
- …Experience.Required Skills: Accounting, Accounting, Adaptability, Asset Accounting, Audit Internal Controls , Contract Audits, Data Analysis, Financial Advising, ... both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will...our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready ... with a less traditional background. **Job Description** The Group Lead , Supply Chain CoE - North America will ...Innovation** - Champion digital technologies (eg, SAP IBP, Kinaxis, Control Towers, AI/ML) to improve agility and decision-making in… more
- Merck & Co. (Rahway, NJ)
- …to new building construction and campus planning?- Have you advised on design standards, project scope, and regulatory compliance as well as act as a liaison with ... selections for capital projects with external consultants and Our Company stakeholders. Lead selection, onboarding, and coordination of outside design and planning… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and ... will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing… more
- Capital One (New York, NY)
- …Services as part of our integration effort. Responsibilities include: Plan, perform, and lead large/complex audits at the enterprise level as well as other diverse ... issues, reviewing and analyzing evidence, and documenting processes. Leverage available data and analytical tools during the planning, fieldwork, and reporting… more
- Merck & Co. (Rahway, NJ)
- …and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible for technical leadership of key ... and technology teams, supply chain, operations, quality, analytical, regulatory, and project leaders. The successful candidate will demonstrate ownership and make… more
- Merck & Co. (Rahway, NJ)
- …and monitoring and, as Product Manager, you'll share leadership with a Technology Lead and work closely with a Product Designer, engineers, delivery leads and ... unmet customer needs and market opportunitiesCustomer & Market Insight Lead continuous discovery: customer interviews, surveys, field visits and advisory… more
- BeOne Medicines (Pennington, NJ)
- …related to cell culture, purification, filling, packaging and OSD. + Participate and lead in controls fault or process fault analysis and remediation. + ... analysis and regulatory inspections. + Digital leadership - Champion and drive Data Integrity, digital transformation and Factory of the Future initiatives at the… more
- Merck & Co. (Rahway, NJ)
- …- In addition, the candidate will be responsible to establish and lead cross-functional teams through the sourcing process and to provide strategy oversight ... with Target; participation in Market Intelligence activities in connection with Target; data gathering and analysis in connection with Target; others that contribute… more
- Merck & Co. (Rahway, NJ)
- …cross-modality technical team. As an individual contributor, the associate director will lead cross functional teams.- The leader will be responsible for executing ... and technology teams, supply chain, operations, quality, analytical, regulatory, and project leaders. The successful candidate will demonstrate ownership and make… more
