- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Global RD/PV QA team .RESPONSIBLITIESProgram oversight: Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs) by reviewing ... on assigned programs and in close collaboration with R&D Quality team members to ensure that the...a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partners to ensure that deliverables are met according to agreed timelines and quality standards. Lead a team of professionals specializing in ... testing strategies and processes to ensure all systems and solutions meet the required quality standards, collaborate with quality assurance teams to ensure… more
- Aequor (Thousand Oaks, CA)
- …(R&D, Operations, and GCO). In this vital role you will support the quality management system team to provide proactive compliance oversight to processes, ... Senior Specialist QA Remote any time zone OK Does the...organization. Under general supervision, provide tactical support activities to Quality Management System Lead . Specific responsibilities include… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …revise documents such as SOPs, work instructions.Develop positive relationship with the QA team , Quality Control, Information Technology, Maintenance, ... QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New...experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …record review and drug product release practices.Develop positive relationships with the QA team , Quality Control, Information Technology, maintenance, ... Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role... members, and peers.Independently makes appropriate and compliant GMP decisions. Lead the establishment and improvement of QA … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …bring to the attention of the operations lead of study team lead . Coordinate and liaise with Daiichi Sankyo QA on site audit and inspection ... Leadership:Has primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical...and quality metrics and share with study team , Operations Program Lead , and Sr. Director… more
- Merck & Co. (Durham, NC)
- … and/or cGMP experienceMinimum of 1 year managerial or team lead experience recommended WORKING RELATIONSHIPS: Reports to Quality Control Associate ... Job Description Job Description: Our Quality Assurance group ensures every single...all activities required to successfully support the QC laboratory Team to include the following: Quality Manager overseeing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research, Research, ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Merck & Co. (Lower Gwynedd, PA)
- …Gwynedd Township, PA.We are seeking a talented, organized, and innovative leader to lead our Laboratory Operations and System Validation team . The successful ... Location :West Point, Pennsylvania (with ~25% travel to Spring House, PA)Responsibilities : Lead a team of staff that span across Laboratory Operations… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …regulations and standards, implementing best practices for workplace safety and employee training. Quality Assurance : Maintain high standards of quality in ... Operations Management: Oversee all aspects of plant operations, including production, quality control, maintenance, and shipping. Team Leadership: Manage, mentor,… more
- Genmab (Plainsboro, NJ)
- …areas for improvement and drive process enhancements.Align GCDS efforts with Quality Assurance , Clinical Strategy, and other stakeholders.Address drug supply ... to support efficient operations.Forecast demand, manage inventory, and prevent stockouts. Lead cross-functional collaborations, including Clinical Project Supply Team… more
- Twist BioScience (South San Francisco, CA)
- …programs for quality professionals on complaint handling, customer service, and quality metrics.Represent the quality team in cross-functional meetings ... We are seeking a highly experienced and motivated Staff Quality Engineer join our dynamic team . As...Sciences, or a related field.10+ years of experience in quality assurance or customer service, with at… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance , Finance, R&D, Project Management and Quality ... information on the request for pricing (RFP) process.Direct and coach cross functional team staff in areas such as quality , compliance, safety, project planning,… more
- Insmed Incorporated (San Diego, CA)
- …to clinical development and operations, regulatory, medical affairs, drug safety, and quality assurance teams, as well as overall program support ensuring ... do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Quality Project Management Specialist as part of the Quality team based in Raritan, NJ. Role OverviewThis position is an exempt ... is preferable that the candidate have 2 years + of experience working in Quality Assurance . Previous cell therapy experience is a plusKnowledge of cGMP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Change Management process. Through careful coordination with stakeholders and consistent quality assurance , minimize the risk of changes, strive for ... in a global environment.Responsibilities- Process Ownership and Coordination. Act as a Lead function and process owner on a global level for Change Management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GxP and Non-GxP systems and services. In this position, the GSM will lead major incident calls, conduct problem management meetings, and drive process and policy ... improvements and workflow efficiencies. The GSM works closely with QA during regulatory agency, partner, and internal audits and...on the global performance of owned processes. Monitor Service Quality and put proactive measures in place to improve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary The purpose of this job is to lead certain pipeline support activities and assist in the identification, coordination assessment, ... meetings; leading negotiation sessions in concert with senior GBD Transactions team members; and alliance management participation following successful completion of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking an Asset Reliability Engineer as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Asset / Reliability Engineer will be ... deployed and maintained following necessary GMP requirements. This person will be the lead for equipment optimizations as well as system upgrades with the systems… more
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