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Under the direction of the Administrative Director for Quality and Patient Safety Operations, the Lead Project Manager for Strategic Quality and Safety Initiatives will provide team oversight and expert project management to a portfolio of cross-functional priorities that support the department’s growth, expand its operating capabilities, and further its mission across the six pillars of quality.
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Reporting to the Director, Quality Control Operations, the Senior Manager, QC Operations and Stability will perform quality control functions supporting drug substance, drug product and cell banks.
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Lead CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis. Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
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Coordinate with Program Leads, Biostatistics, Data Management, Medical Affairs, Pharmacovigilance to develop/implement Phase appropriate procedures to ensure consistency and quality with respect to Clinical Trial support activities.
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Oversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliation. Innova Solutions Client is immediately hiring for a Manager/Sr Manager, Data Management.
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Requires a BS in health administration, nursing, or a related clinical field; 4 years of health care quality or data analysis experience; or any combination of education and experience, which would provide an equivalent background.
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The position will utilize audit and inspection intelligence, SOP development, training and risk mitigation plans to assure adherence to GCP/GPV requirements in conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.
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The Manager, Product Quality Complaints has the responsibility for implementing and maintaining the Product Quality Complaint Process for Azurity Pharmaceuticals, Inc. This position will report to the Associate Director, Quality Operations.
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The selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
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Work experience should include a combination of data management and quality control experience in pharmaceutical product development and/or commercialization. The Manager, Quality Control has responsibility for actively overseeing cGMP quality control activities associated with development and commercialization of the company's small-molecule assets.
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Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP or GCP preferred.
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Review and comment on data from contributing departments to ensure accurate and complete documents for inclusion in regulatory standards (UDI, IFU, Labeling, Packaging, Marketing) docs. Independently manage interactions with clinical monitors, data management, safety, regulatory, and QA team members, both internally and externally in mitigations to the product release.
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The Quality Manager is responsible for implementation of new customer processes, including design and development of production fixtures and workflow documentation. Collect data and provide data analysis, interpretation, and trending derived from the Inspection Access database or other data sources, including tracking of management-defined KPI’s.
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Advanced knowledge in the management of quality events and GCP deviations, inclusive of conducting robust root cause analysis and developing CAPA plans that mitigate risks to the company, to safety and data integrity.
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The Manager will oversee GCP activities across various areas of development, ensuring compliance, and quality execution of clinical trials. Our Clinical Quality team is growing, and we are currently recruiting for a Manager/Sr. Manager of GCP Clinical Quality Assurance.
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data quality jobs Title: quality manager in Lexington, MA
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