- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matter experts (SMEs), and other functional area partners to ensure GCO risk management activities are executed and continuously monitored for effectiveness, ... to ensure a continued practice centered on Quality by Design, Clinical Trial Risk Management , efficient Issue Management , and Continuous Improvement.Supports… more
- Eisai, Inc (Nutley, NJ)
- …, goal/mission/objective setting, aligning with stakeholders, driving outcomes Experience with risk management principles, articulating the risk and ... oversight of mitigation/resolution, confirmation, reporting and trending. 3. Program Management and oversight to identify, catalogue and close out Security… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program level and along the GvP modules in support of a proactive quality risk management process.Interact with the audit and compliance function for the ... of PV risks identified through audits, inspections, internal meetings, remediations and risk management in close collaboration with the organization's quality … more
- Insmed Incorporated (San Diego, CA)
- …functional and cross-functional teams and ad hoc project team meetings Conducts the risk management and scenario planning and develops contingency and/or risk ... The Associate Director of Program Management will utilize best-in-class program management support to provide end-to-end oversight of the program strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and Oversight : Responsible for the oversight , performance, and ... written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally… more
- Merck & Co. (North Wales, PA)
- …DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division organization of our ... full potential. The Associate Director is expected to provide project management leadership and drive cross-functional teams with sufficient influence and mastery… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …procedural document and/or procedural document package update(s). Cross-Functional Procedural Management Related to Vendor Alliance and Oversight :As needed, ... Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management , will be accountable for the authoring and lifecycle management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …organizational performance objectives. The incumbent will be responsible for providing oversight and co-leadership of the investigation management system, ... Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and leadership for the investigations … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible to support Clinical ... to help facilitate the inspection readiness mindset.Facilitates clinical quality risk identification and the necessary problem solving and corrective measures… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with other Leadership Team members to optimize processes, resource allocation, and risk management strategies leveraging project management tool ... and track the hiring timeline according to plan, identify risk or gap for timely escalation and develop contingency...and plan agendas weeks ahead of schedule.- PM/OE Team Management and Development, Vendor Oversight :- Lead and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for investigative sites to support their efforts in reaching diverse communitiesPeople Management : May manage staff which would include oversight , training and ... GCO to: 1) Lead and implement the establishment and oversight of an Inclusive Research and Patient Voice Strategy...review and analysis of site level activities through targeted risk -based site contacts and on-site visits to monitor study… more
- Aequor (Thousand Oaks, CA)
- …senior engineer works in partnership with the automation, maintenance, project management , corporate engineering, and manufacturing to develop and oversee the ... and safety. Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …has moderate skills in continuous improvement, project management , change management , and risk management . Responsibilities Leadership, Direction, and ... (eg, study startup, study conduct, study closeout, and reporting).Provides oversight for Data Management CRO and other third party vendors to ensure compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external network. Manages Phase 1 - ... questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)May participate in Site Initiation Visit (SIV)… more
- Aequor (Thousand Oaks, CA)
- …Oaks (ATO). The engineer works in partnership with the maintenance, Project Management , Engineering Technical Lead, and manufacturing to develop and oversee the ... Oaks (ATO). The engineer works in partnership with the maintenance, Project Management , Engineering Technical Lead, and manufacturing to develop, improve and oversee… more
- Aequor (Thousand Oaks, CA)
- …and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Quality Management Systems. offers the opportunity ... the Product Development Team (PDT). The PQL provides scientific oversight for the product quality of pivotal and/or commercial... of the product stability programs, providing indirect staff management and guidance to members of the PQT. Key… more
- Merck & Co. (Durham, NC)
- …substance or drug product.GMP experience with qualification of equipment.Experience with Quality Risk Management .Project Management experience in a highly ... product.- The focus for the position includes all aspects of Quality oversight for drug product, drug substance, media preparation, and sterile supply.Position… more
- Aequor (New York, NY)
- …on-boarding process with GCS business goals. In addition to exemplary relationship and risk management , this role requires significant use of systems and data ... GCS contractor and supplier staff demand forecasts. Lead associated onboarding and oversight with business lines across GCS. Use technical operational and Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and identified risks for select products during development. Assist teams in maintaining oversight of changes to the benefit/ risk balance. Provide expert input ... Sankyo's global drug portfolio from the Research stage to post marketing/lifecycle management . Our expectation is that the person filling this role will pioneer… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
