- Legend Biotech USA, Inc. (Raritan, NJ)
- … Quality team based in Raritan, NJ. Role Overview The QA Investigations Lead has the responsibilities for providing quality oversight over the production of ... multiple myeloma. Legend Biotech is seeking a QA Investigations Lead (2nd or 3rd shift) as part of the...investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and… more
- Insmed Incorporated (Bridgewater, NJ)
- …in Design Control Process for medical device products and combination products. Lead the quality assessment for product lifecycle changes, efficiency ... York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play… more
- Insmed Incorporated (Bridgewater, NJ)
- …Excellence (FME) will develop field medical functional strategy to enable high- quality , impactful customer engagements with a consistent approach worldwide. The FME ... The Director of Field Medical Excellence will establish and lead worldwide Field Medical Excellence Forums.ResponsibilitiesField Medical Strategy - Develop… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …therapy platforms. Work cross-functionally across Technical Operations and interface with external vendors to drive the design and implementation of automation ... and receiving sites. Build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless implementation of technical transfer activities and/or… more
- Insmed Incorporated (Bridgewater, NJ)
- …for being the Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic ... cross-functional interaction between lead optimization research and early CMC development.Responsible for the management of API/Intermediate/RSM manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Supervise a team of QA Investigations Leads. Provide guidance to the Quality Leaders about handling the various nonconformances. Lead the daily ... QA Investigations Supervisor (2nd shift) as part of the Quality team based in Raritan, NJ. Role Overview The...touch point meetings with the team and monitor workload. Lead the daily triage meeting for nonconformance initiation. Support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the completion of corrective and preventive actions, as necessary. Supports internal/ external audits. Supports Quality risk assessment teams. Review/approve ... seeking QA Shop Floor Supervisor as part of the Quality team based in Raritan, NJ. Role Overview The...supervising employees is preferred. Ability to work with and lead others in a team environment. Demonstrated ability to… more
- Insmed Incorporated (Bridgewater, NJ)
- …responsibilities will include, but not necessarily be limited to, the following: Lead strategic communication & dissemination of HEOR Evidence to internal and ... external stakeholdersEnsure HEOR communication tools (eg medical/payer presentation decks...analysis plans, reports and publications building on the high quality and scientific rigor of these deliverables Represents HEOR… more
- Insmed Incorporated (Bridgewater, NJ)
- …the quality of statistical analyses by CRO or internal teams. Lead or contribute to statistical innovation activities including innovative design, advanced ... responsibilities will include, but not necessarily be limited to, the following: Lead one or several indications corresponding to one or several compounds… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …across programs. Acts as a primary point of contact for escalations related to quality of external data delivery. Identify quality issues pertaining to ... management deliverables for assigned DS Program / Studies by ensuring consistency of external data standards.Is accountable for quality delivery of diverse … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a team-based environment, on an assigned production shift schedule. Key Responsibilities Lead and supervise multiple units within the CAR-T process operations (ie ... records and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead the daily start of shift operations meetings, the daily wrap up… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …This individual will be responsible for a global operational strategy and investigations lead / owner for a best-in-class high volume marketed CAR-T product as part ... and implements changes/ improvements and ensures continuity amongst sites and external CMO partners Drives plans and technology integration for facility… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data standards. Acts as a point of contact for escalations related to external data delivery quality . Ensures consistency in understanding and implementation of ... external data standards. Promotes Daiichi Sankyo values and quality workplace culture, collaboration in cross-functional and multicultural settings, and builds… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to global Development governance. In this key role, the candidate will have to lead a complex, global team in charge of a global clinical program designed to ... representative of asset through the lifecycle from research to post-marketing functions. Lead all GPT meetings, ensure team and cross functional alignment, positive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and ... the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead ...with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate… more
- Insmed Incorporated (Bridgewater, NJ)
- …responsibilities will include, but not necessarily be limited to, the following: Lead complex clinical trials or indication corresponding to one or several compounds ... and reporting of clinicals.Manage the timelines and oversee the quality of statistical analyses by CRO or internal teams.Undertake...the discretion and latitude required in the role, and external market and internal value when determining a salary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan ... Study Manager will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan ... and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the oversight of and… more
- Merck & Co. (Rahway, NJ)
- …of the Research & Development division.The Associate Director, PMO People & Process Lead , is a unique role that will be heavily client-facing, accountable for ... the training forum; accountable for curating and defining a quality annual calendar of topics that achieve the purpose...for our community of clients that grows over time.Delivery lead for PMO Project Management onboarding training and PMO… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before ... Represents Clinical Development in Project Teams, possibly as Global Clinical Lead .Responsibilities:Medical Monitoring Planning (MD Only): For large Phase 2 or Phase… more
