alnylampharmaceuticals · Maidenhead, UK
Overview: The Senior Manager, R&D Quality Assurance independently performs the R&D QA Program Lead role for assigned clinical studies, providing Clinical Quality Assurance oversight in accordance with study protocols, company procedures, GCP requirements, and applicable local and international regulations. The role leads and supports quality oversight, audit, and inspection-readiness activities and works cross-functionally to identify, assess, mitigate, and escalate quality and compliance risks. The Senior Manager also provides guidance and oversight to junior R&D QA staff, as applicable, and supports continuous improvement activities within R&D Quality Assurance. This is a hybrid role that can be based in Cambridge, MA; Philadelphia, PA; or Maidenhead, UK, with three days per week onsite. Key Responsibilities: Independently perform the R&D QA Program Lead role for assigned clinical studies, providing Clinical Quality Assurance oversight in accordance with study protocols, company procedures, GCP requirements, and applicable local and international regulations, with escalation to the GCP QA Director as appropriate. Provide quality oversight for assigned clinical studies, including identification, assessment, mitigation, and escalation of quality and compliance risks and support for the investigation and resolution of Quality Events and CAPAs. Lead and support GCP audit activities, including investigator site, vendor, study, and process audits, as applicable, and ensure audit observations and associated corrective and preventive actions are appropriately addressed. Lead inspection-readiness activities for assigned clinical studies, including coordination of QA and cross-functional activities, identification and mitigation of potential inspection risks, and preparation for FDA, EMA, PMDA, and other Health Authority inspections. Establish and maintain effective working relationships with internal Alnylam Expertise Area leads, study teams, vendors, and external partners…
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