- Legend Biotech USA, Inc. (Raritan, NJ)
- …that would provide reduction in COGs, increase throughput, capacity and quality compliance .Provide technical expertise in automation projects from user ... lead investigations to ensure process integrity and GMP compliance . Additionally, the role includes overseeing and enhancing manufacturing standards,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational ... and result in outcomes that demonstrate the Company's dedication to regulatory compliance .Ensures that a cross-functional team (eg Quality & Continuous… more
- Repligen (Waltham, MA)
- …- Quality Network Leader , Chromatography & Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance to ISO 9001 ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,...as host for site auditsMaintain risk-based strategy for overall Quality compliance across the organization and in… 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 ... Clinical Quality Assurance, the Director of Clinical Quality Assurance (CQA) serves as a strategic leader...cross functional working groups to identify and mitigate GCP quality and compliance issues.Supports the evaluation and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in ... Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems processes within… 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 ... high impact projects, fostering s culture of excellence and compliance and working toward building a quality ...Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality… more
- Merck & Co. (Millsboro, DE)
- … compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for audits, inspections, validations and corrective actions.Author, review ... leaders and frontline teams, and who works effectively across functional partners. Quality - and compliance -focused with practical experience supporting regulatory… 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 ... of CAR-T drug product for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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. ... Investigation Supervisor within the Raritan Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance… more
- Insmed Incorporated (San Diego, CA)
- …and implementation of EDC systems to support clinical trials, ensuring data quality , compliance , and efficiency throughout the study lifecycle. The AD, ... Best Medium Workplaces™ lists.OverviewThe Associate Director, EDC Programming will lead and oversee EDC programming, and database build for...GCP, 21 CFR Part 11, and CDISC ODM StandardsData Quality & Compliance :Ensure EDC systems comply with… more
- Merck & Co. (North Wales, PA)
- …the entire product lifecycle for the assigned projects. Assure deliverable quality and process compliance .Responsible for effective deliverable development ... Job DescriptionPosition description:- Lead the statistical programming activities for multiple and/or...standards and demonstrated success in the assurance of deliverable quality and process compliance also required.Must possess… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …on preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she ... following necessary GMP requirements. This person will be the lead for equipment optimizations as well as system upgrades...failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing… more
- Merck & Co. (Durham, NC)
- …during tours to provide area/process overview information to visitors/auditors upon request-- Quality & Safety Compliance - Foster strong safety culture on the ... reporting safety issues and completing corrective/preventative actions-Drive culture of compliance through actions, consistent quality -driven decision making,… more
- Merck & Co. (Rahway, NJ)
- …and Manufacturing divisions.Interface with external suppliers and partners to ensure the quality and compliance of components used in Autoinjectors, driving ... expertise in the design, development, and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA… more
- Merck & Co. (Rahway, NJ)
- …principal scientist will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices ... and/or the Head of the Crystallization Lab, the principal scientist may lead strategic technical initiatives and support talent development of junior engineers.A… more
- Merck & Co. (Rahway, NJ)
- …sustained launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities: Strategic ... syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to...team members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance: Ensure that all… more
- Merck & Co. (Rahway, NJ)
- …sustained launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize extensive ... expert on the device components and combination products and lead a cross functional team members to support global...activities are conducted with the highest regard for safety, quality , and regulatory compliance , aligning with the… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.- Position Description - This is a… more
- Merck & Co. (San Diego, CA)
- …the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation.Interact independently with ... accelerate approvals and optimize product labeling.This position requires an experienced leader who is proactive, self-motivated and who can independently manage… more
- Merck & Co. (Durham, NC)
- … quality without compromising superior customer service. FUNCTIONAL EXPERTISE: Lead in the identification and implementation of process improvement projects, ... and implementation of preventative and predictive maintenance programs to assure compliance with quality , regulatory, and reliability requirements and… more
