Sr Manager QA Technical Operations

Role: Senior Manager of QA Technical Operations overseeing quality control and compliance in biopharma manufacturing. Responsibilities: supervise QC projects, manage daily QA activities across Cell Banking, Change Controls, Technology Transfer, Automation, Validation, MS&T, and Site Engineering; support regulatory audits; lead investigations, approve change controls, protocols, and reports; review manufacturing maintenance and calibration schedules; manage technical transfer documentation approval; collaborate with cross-functional teams in clinical and commercial tech transfer meetings; track and mitigate transfer risks; develop training programs for direct reports; participate in regulatory inspections and audits; hire and develop high-caliber talent. Requirements: B.S. in science, engineering, or related field; minimum 8 years in biopharma operations with experience in quality assurance, compliance, and manufacturing of biologics or cell/gene therapies; prior management experience preferred; knowledge of US/EU cGMP regulations and regulatory authority interactions; proficiency with systems like SAP, LIMS, Veeva Vault. Preferred: experience with biotech bulk/finished product manufacturing, analytical testing. High-Value: biologics, cell/gene therapy, quality assurance, technical transfer, regulatory audits, GxP, cross-functional collaboration. Location: onsite Devens, MA, with flexible work arrangements. Travel: not specified.