Sr. Manager, R&D Quality

Role: Senior Manager, R&D Quality at a biopharma focused on autoimmune and rare diseases, overseeing quality assurance activities across clinical development. Responsibilities: manage the Quality Management System, conduct audits (investigator, vendor, systemic), support inspection readiness, oversee vendor qualification and oversight, ensure data integrity and TMF compliance, author SOPs, lead process improvements, and promote a quality culture through training. Requirements: Bachelor's in Life Sciences or related field; 8+ years of biotech/pharmaceutical R&D QA experience; deep knowledge of FDA, ICH, and EMEA regulations; strong leadership, communication, and project management skills; proficiency in GxP standards and Microsoft Office. HighValue: experience in clinical QA within biotech/pharma, familiarity with GLP, GCP, GVP, and risk-based quality management; hands-on with audits, vendor oversight, inspection support, and data integrity in clinical systems; focused on cGMP compliance and continuous improvement. WorkSetup: office-based in Waltham, MA, with a 3-day in-office requirement per week.