- Legend Biotech USA, Inc. (Raritan, NJ)
- …inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend standards , procedures and ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … quality and compliance input for continuous improvement; and remediations. Lead quality driven continuous improvement projects to reduce turnaround time ... This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team, responsible for ensuring adherence to regulatory requirements and internal quality standards across cell and gene therapy manufacturing processes. ... that would provide reduction in COGs, increase throughput, capacity and quality compliance .Provide technical expertise in automation projects from user… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2) ... product profile (TPP) development, due diligence projects, and clinical-regulatory compliance . ResponsibilitiesEssential Duties and Responsibilities Clinical Development: Design and… more
- Merck & Co. (Durham, NC)
- …technical solutions and operational improvements to achieve targets for safety, compliance , supply, and productivity for the product franchise.This role requires a ... maintain strong and trusting relationships with site technical operations, quality , regulatory, stability, and other stakeholders to ensure effective communication… more
- Insmed Incorporated (San Diego, CA)
- …managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other ... direction with cross functional working groups to identify and mitigate GCP quality and compliance issues.Supports the evaluation and acceptability of vendors… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality execution across Medical Affairs programs, ensuring compliance ... activities with the goal of achieving the highest data quality standards , full adherence to patient's rights...development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process for… more
- Merck & Co. (Rahway, NJ)
- …matter expertise in the design, development, and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO ... and Manufacturing divisions.Interface with external suppliers and partners to ensure the quality and compliance of components used in Autoinjectors, driving… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams on key milestones relating to the tracking of a particular signal(s) to ensure compliance with global Sops. Lead the maintenance of signal tool and support ... and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures… more
- Merck & Co. (Durham, NC)
- … groups to ensure facility operations and systems comply with required standards . Lead / participate in discussions with contractors, vendors, or other third-party ... quality without compromising superior customer service. FUNCTIONAL EXPERTISE: Lead in the identification and implementation of process improvement projects,… more
