- Novo Nordisk Inc. (Plainsboro, NJ)
- …and make the appropriate changes to ensure trial conduct is completed in compliance and meets Novo Nordisk's business standards Risk management: Assessing and ... ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and...needs are met through alignment of business plans and operational need within the Therapy Area and OED to… more
- Merck & Co. (Rahway, NJ)
- …Plant leverages significant depth and breadth of scientific, technical, and operational experience to lead and support facility operations, process development ... activities, compliance investigations/change management, authoring of GMP documentation, and lead...pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the… more
- Merck & Co. (Rahway, NJ)
- …Clinical Quality Operations Manager (CQOM) is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes ... operational quality management and inspection management activities. The position...`quality by design` within clinical development programs, using a risk -based approach. They will be responsible for the overall… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at ... that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external stakeholders… more
- Merck & Co. (Durham, NC)
- …new HPV vaccine drug substance manufacturing facility. As a direct report to the Director of Operations, the Associate Director will be accountable for the ... comprehensive technology transfer of the HPV vaccine manufacturing process while ensuring compliance with all regulatory and safety guidelines. Lead a diverse team… more
- Merck & Co. (Rahway, NJ)
- …Trust security strategy across the organization, with a particular focus on Operational Technology (OT), Identity and Access Management (IAM), and Cloud Native ... and design appropriate security controls.Conduct in-depth analysis of our Operational Technology environment, identifying potential vulnerabilities and recommending mitigation… more
- Insmed Incorporated (Bridgewater, NJ)
- …processes. This position will be accountable for all necessary strategic planning, risk management, operational execution and communication required for the ... Development Plan and associated functional plans. As a leader, the Sr. Director of Program Management will provide cross-functional operational and program… more
- Merck & Co. (Rahway, NJ)
- …on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot ... candidate will be able to immediately step in and provide operational support to controls and automation activities throughout the facility.-Primary… more
- Merck & Co. (Rahway, NJ)
- …tracking TCO and other standard financial toolsAd-hoc initiatives to support operational financial management of the platform budget and forecastStrong partnership ... and alignment with EIT Finance and IT PMOEnsure compliance with IT financial controls and standardsQualifications, Skills & Experience: The ideal candidate will have… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …skills in continuous improvement, project management, change management and risk management.Responsibilities Project level AI/ML activities - Responsible, with ... direction and execute oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, applicable regulatory guidelines, policies,… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... safety reports, periodic safety reports, signal detection activities and risk management planning. The incumbent works cross-functionally with counterparts/teams in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …require proven skills in continuous improvement, project management, change management, and risk management. The position will act as main statistical contact for ... matter expert in meeting or teleconferences with Health Authorities. Ensure compliance with international regulations. Ensure inspections readiness as well as… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance , the Director , Quality Operations ... critical suppliers. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality, consistent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Senior Director , Global Head of CR2 Project Management & Operational Excellence is responsible for supporting the Global Head of CR2, the assigned ... Head of Centre for RWD / RWE (CR2) Project Management and Operational Excellence (PM-OE) will lead innovation, coordination, and strategic planning efforts and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in continuous improvement, project management, change management, and risk management. ResponsibilitiesLeadership, Direction, and Strategy:Provides data management ... for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable… more
- Merck & Co. (Durham, NC)
- …with strong interpersonal, leadership, and collaboration skills responsible for supporting Operational Readiness projects to support biological processes for a new ... and business plan; receives guidance and oversight from Operations Associate Director and Director ;Interprets client and/or customer needs and assesses… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may ... the Sr. CSM to take the role of both operational strategy and study execution. ResponsibilitiesStudy Management & Leadership...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Merck & Co. (Rahway, NJ)
- …and area leadership to ensure delivery of business objectives, including operational efficiencies, compliance , energy savings initiatives, improved reliability, ... responsibility. The Specialist - Manufacturing Automation position will report to the Director , Engineering, Automation Lead position and will be a member of the… more
- Truliant Federal Credit Union (Winston-Salem, NC)
- …and rewarded for all that they do. Purpose of the JobThe Director , Credit Administration is responsible for the overall leadership, performance, and administration ... while maintaining a member focused service culture and regulatory compliance . Essential Functions and ResponsibilitiesResponsible for organizing, planning, and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …for operating cross-functionally, collecting necessary data and information associated with operational deviations and a champion for quality priority principles and ... compliance within the organization. This is an onsite based...with relocation assistance eligible for selected candidate.Relationships Reports to: Director of MSAT & Quality Control Number of subordinates… more
