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Represent the Quality Assurance Validation group in project teams, audits, and inspections. Provide quality guidance on process qualification, and continuous process verification strategies for gene editing components (i.e., oligonucleotide guide, CRISPR endonuclease, and ribonucleoprotein [RNP] complex) and ex vivo CRISPR gene-edited cell therapies manufactured internally and at CMOs.
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ElevateBio is looking for a Cell Therapy Manager, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Manager will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events.
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Quality Assurance Manager. Maintains Quality Assurance hold accuracy, identifies causes of deviations, and takes corrective actions. Operate as the plant’s SQF Practitioner and manages all food quality, Kosher and safety programs including HACCP.
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The Sr Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as varied vendors supporting Clinical Studies.
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We are seeking a Senior Manager/Associate Director, Quality Assurance, Systems to join our team. Senior Manager/Associate Director, Quality Assurance, Systems.
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Experience working in development and commercial phase companies in a Quality Assurance function. This position reports to the Director, Quality Assurance, Systems and will be in Boston, MA, USA. The level of the position will be commensurate with the candidate’s education and industry experience.
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Works with the appropriate offsite and main campus leaders, which include but not limited to, the DFCI Laboratory Senior Director of Operations, Operations Manager, technical supervisors, quality managers, the supervisor of specimen processing, and the laboratory information system team, acts as a resource to address laboratory service concerns for regional sites to review and provide input to maintain and improve service for regional patients and providers.
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Inform in timely manner the escalation of any deviation or major or critical complaints to direct manager or the VP Quality Pharmaceutical Development, Ensure the follow-up of the projects for which he/she is responsible with his/her manager and ensure alignment with Pharm dev Quality Department managers.
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Quality Assurance (QA) Manager (Senior Manager, DOE) Minimum of 8 years of Quality Assurance experience in biopharmaceutics with a minimum of 3 years in human cell therapy platforms.
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Ability to manage and coordinate personnel, as well as organize and drive performance of the quality assurance system. 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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This individual will report to the Sr. Director of Global GCP/GLP compliance and while working closely with the US Site VP and the Global Quality team. They will play a key role in expanding and shaping US-based Quality culture, including GCP and GLP compliant business units.
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The Manager/Senior Manager of Quality Assurance provides oversight of GMP activities for Quality Control Release and Stability testing including method validation and transfer.
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The Manager, GCP Quality Assurance will provide expertise and guidance on Good Clinical Practice (GCP), applicable regulations to clinical and nonclinical development teams to proactively identify compliance issues/risks and recommend mitigation.
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Manager, Coding Validation and Quality Assurance. The Manger, Coding Validation and Quality Assurance may help represent the Clinical Documentation Coding Integrity (CDCI) Department at clinical meetings when requested to serve as a resource for coding guidelines and interpretation.
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Our Clinical Quality team is growing, and we are currently recruiting for a Manager/Sr. Manager of GCP Clinical Quality Assurance. 5+ years of direct GCP pharmaceutical/biotechnology experience in Clinical Quality Assurance auditing.
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quality assurance jobs Title: quality assurance manager in Waltham, MA
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