- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... and Preventive Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … quality experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... an SME during the execution of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... process validation, shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation,… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Clinical Quality Assurance Professional (QAP) position is responsible for design, delivery and execution ... of the global Clinical Quality Assurance (CQA) strategy including audit and...clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in Clinical Quality /CQA conducting… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is ... delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and...Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard… more
- Insmed Incorporated (San Diego, CA)
- …of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on ... for potential use and provides direction, guidance and strategy for company Quality Assurance .Full understanding of and practical experience establishing and… more
- Merck & Co. (Rahway, NJ)
- …performance of team members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance : Ensure that all ... sustained launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities: Strategic… more
- Repligen (Waltham, MA)
- …issues through appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering, Quality ... team. You will a key role in ensuring the quality , compliance , and performance of Repligen's global...in supplier quality engineering, manufacturing engineering, or quality assurance . Proven experience with ISO 9001… more
- Repligen (Waltham, MA)
- …the biotechnology industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product ... meetings with the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance .Maintain internal and external audit schedules; serve… more
- Merck & Co. (North Wales, PA)
- …ADaM standards and demonstrated success in the assurance of deliverable quality and process compliance also required.Must possess broad knowledge and ... the entire product lifecycle for the assigned projects. Assure deliverable quality and process compliance .Responsible for effective deliverable development… more
- Merck & Co. (North Wales, PA)
- …Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance . Strong working knowledge of reporting processes ... that project plans are executed efficiently with timely and high quality deliverables.-For assigned projects the position serves as the statistical programming… more
- Merck & Co. (North Wales, PA)
- …CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance .Strategic thinking - ability to turn strategy ... that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming… more
- Merck & Co. (Rahway, NJ)
- …and tracking performance against forecasts.Collaborate with cross-functional teams, including quality assurance andregulatory affairs, and operations, to ... and benefits DD&T lab operations.Collaborate across DD&T sub-functions, regulatory affairs, quality assurance , Pharmaceutical Operations, Analytical R&D, and ITa… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic collaboration with other GxP Quality representatives, and act as the Quality Assurance point person for all GxP matters within the Medical Affairs ... high impact projects, fostering s culture of excellence and compliance and working toward building a quality ...and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director's Medical… more
- Merck & Co. (Rahway, NJ)
- …advisor for all teams working on Autoinjectors, fostering collaboration among engineering, quality assurance , regulatory, and manufacturing teams across the CMC ... and Manufacturing divisions.Interface with external suppliers and partners to ensure the quality and compliance of components used in Autoinjectors, driving… more
- Tris Pharma (Monmouth Junction, NJ)
- …contract negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company ... control systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality , and regulatory standards in warehouse… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and clinical project management competencies within Clinical OperationsWork in collaboration with Quality Management and Quality Assurance to develop and ... external vendors to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study teams. This leader will also ensure a… more
- Formation Bio (New York, NY)
- …obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and Data Governance teams to understand and monitor vendor ... procurement policies, procedures, and governance frameworks to ensure consistency, compliance , and cost discipline. Collaborate with finance, legal, R&D,... compliance with company policies, industry regulations (eg, FDA, EMA,… more
- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, ... Response Letters (CRLs)Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and cGMPs; Cleans… more
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