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Reporting directly to the Senior Manager of Quality, this position collaborates closely with External Manufacturing Organizations (EMO), spanning pharmaceuticals, medical devices/combination products, consumer products/OTC, and biologics sectors, ensuring adherence to cGMP regulations and Bausch Health requirements.
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We are seeking an innovative and highly motivated Senior Manager, Quality Operations, who will contribute significantly to the growth of the Cellares team. 10+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC.
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Reporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments.
$207,000 - $289,867 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Coordinates and leads EMQA personnel through the Compliance Wire, Remarque (TrackWise) system which includes but not limited to Quality Events, Management of Change, Supplier Quality Management, Audits and CAPA workflows.
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Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Laboratory Quality Control - CAR-T in Raritan, NJ! Work with Process Development team, Quality, and Operations organization to successfully transfer process testing to cGMP facility to manufacture products.
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Team Leadership: Provide leadership, guidance, and mentoring to a team consisting of Travel Agent, Supplier Diversity Manager, Analytics Manager, Analytics Analyst, and Buyer(s). Supplier Diversity: Lead the Supplier Diversity Manager in promoting diversity and inclusion within the supplier base.
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Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices and ICH E-6 for Good Clinical Practice. Facilitate and maintain a risk-based and scientific-based quality system to support Good Pharmacovigilance Practice (GVP.
$200,000 - $280,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Act as a program manager for continuous improvement of processes that improve service, quality, or cost. Reporting to the Director of EMSI, the Manager, Analytics and PP&L is responsible for providing oversight and integration of all outsourced activities.
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Analytics and Reporting: Oversee the Analytics Manager and Analytics Analyst in gathering, analyzing, and reporting data related to procurement activities. Vendor Relationships: Build and maintain relationships with suppliers and vendors to ensure alignment with company objectives and quality standards.
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Ethicon is recruiting for a Senior Manager of Quality Systems, primary location in Raritan, NJ. This position can also be based at any other Ethicon location in North America, Puerto Rico, Mexico or Brazil.
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Author, document, review quality record documentation including NC, RCI, FI and other areas of quality engineering/validation, spreadsheet validation, and equipment qualification. Track and trend quality data for non-conformances, RCI, CAPA and Change Control.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Then consider joining us as a Quality and Safety Manager in Piscataway, New Jersey! Knowledge of quality systems (GxP, ISO, Lean, TPS, etc.) You will be responsible for the overall quality and safety for the full environment of our new distribution center.
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The Quality technician provides constant supervision and support to the Pilot Plant while promoting a Food Safety culture on site. Work with the Pilot Plant Manager on the batch records and continuous improvement initiatives.
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Work with the Pilot Plant individuals on reporting quality deviations and taking immediate corrections. Active Quality representation in the Pilot Plant, facilitating the communication within the Pilot Plant team, the QA Department and Analytical Lab.
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Assist the Vice President Quality Assurance maintain a Reinsurance Claims Quality Assurance Program focused on assessing quality of technical claims handling, ensuring high quality claims handling for Everest, and identifying areas for improvement across the Global Reinsurance Claims Department.
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Title: quality manager Company: Ks Engineers P C in Bridgewater, NJ
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