- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role OverviewThe Quality Systems Lead ... multiple and complex cross-functional projects with many stakeholders.Support other quality systems activities, as needed.Support drafting, review and… more
- Repligen (Waltham, MA)
- …KPI's and management review meetings with the Senior Management team .Facilitate operational excellence initiatives in Quality Assurance.Maintain internal and ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,...the Management Representative to the ISO 9001 registrar.Manage the quality team responsible for complaint handling for… more
- Merck & Co. (Rahway, NJ)
- …and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design ... / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound...and shown to be able to motivate, influence scientific team ; lead by example through past scientific… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …controls, and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review meetings and sponsor various ... Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Director of Operations is an exempt… more
- Merck & Co. (Durham, NC)
- …problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements. Review and approve out of tolerance (OOT) ... needs to identify solutions.Works as a liaison between Maintenance, Deviation Management, Quality and other Site Business Partners.Initiate, Review or Approve… more
- Merck & Co. (Durham, NC)
- …coordinate, provide guidance and counseling to group leaders to assure optimum quality and quantity of finished products.Keep all team members informed ... a direct GMP, biotechnology, manufacturing setting.Required Experience and Skills:Demonstrated ability to lead a team (ie experience leading directly as a… more
- Merck & Co. (Durham, NC)
- …problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements. Review and approve out of tolerance (OOT) ... for calibration technicians.Works as a liaison between Maintenance, Deviation Management, Quality and other Site Business Partners.Initiate, Review or Approve… more
- Aequor (Houston, TX)
- …of supervisor/manager o Generously shares information and knowledge with others across the team o Routine interaction with Quality Assurance (Raw Materials) and ... cross-functional setting, and participation and attendance at the deviation review board o Management of multiple projects and timelines...Teamwork Dependable and able to work well within a team . Routine interaction with Quality Assurance and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …document verification and targeted source data review . Lead the team to develop and implement metrics including Quality Tolerance Intervals, Key Risk ... leverages external expertise in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical… more
- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control/QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 am ... manner while also serving as a resource for the review of quality documentation received from interdepartmental...and procedures related to performing assigned tasks.Collaborating with the team to resolve issues, maintains time lines and plans… more
- Merck & Co. (North Wales, PA)
- …may include:Serving as the lead clinical scientist on the clinical trial team .Leading medical monitoring team in review and interpretation of clinical ... and scientific acumen as part of a global, cross functional team .Job ResponsibilitiesResponsible for leading specific aspects of clinical/scientific execution of… more
- Merck & Co. (Upper Gwynedd, PA)
- …of supporting documentation to confirm acceptability and identification of potential risks. Lead the development, communication, lifecycle management and review ... include, but are not limited to:Regulatory Responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory… more
- Merck & Co. (Durham, NC)
- …and Medical Devices used to deliver Pharmaceutical, Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary ... business. Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant… more
- Eisai, Inc (Nutley, NJ)
- …strategic plan for assigned therapeutic area(s). These deliverables include development and review of compliant scientific exchange materials to be used in external ... will work cross-functionally as a strategic partner with the broader Medical Affairs team as well as the Publications & Scientific Communications teams and other… more
- Genmab (NJ)
- …timelines, facilitate meetings, and lead review cycles.Provide expert peer review and editing support to elevate the quality of documents across the ... impact in oncology drug development and be part of a dynamic, collaborative team that values innovation, quality , and scientific integrity? At Genmab, we… more
- Formation Bio (New York, NY)
- …biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC team ... are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team… more
- Merck & Co. (Rahway, NJ)
- …clinical/scientific execution of clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team . Leading medical ... leadership, technical skills, and scientific acumen as part of a global, cross-functional team . - Job Responsibilities - Responsible for leading specific aspects of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with all company policies and regulatory guidelinesHelps improve metric performance to drive team results in areas of EHS, quality , compliance, cost, delivery ... Metrology Technician I/II as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will...parts and spare parts are identified and availablePerforms work review , approval and close out of work orders, including… more
- Eisai, Inc (Nutley, NJ)
- …to the company's products. The incumbent will contribute to the development of high- quality Medical Information deliverables within the team and will be a ... scientific information within the department and cross-functionally. May serve as project lead to develop and update AMCP Formulary Dossiers for Eisai products.… more
- Eisai, Inc (Exton, PA)
- …Upstream and Downstream is responsible for leading and building a scientific team focused on the technology transfer, scale-up, and optimization of validatable ... with other Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC...R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs at… more
