Director, Quality

Role: Lead Quality Operations at a biopharma manufacturing and distribution site, responsible for maintaining ISO 9001 compliance, overseeing Quality and Incoming Quality Control teams, and fostering a culture of quality and continuous improvement. Responsibilities: manage QMS activities including audits, CAPA, validation, change controls, and complaint handling; partner cross-functionally to drive quality initiatives; author and revise procedures; ensure training effectiveness; communicate quality guidance; develop quality metrics and support operational excellence; oversee audits and supplier quality collaboration; review validation plans, deviations, investigations, and corrective actions; mentor and develop direct reports. Requirements: Bachelor's in Engineering, Biology, or Chemistry; 10+ years in cGMP, ISO 9001/13485 environments; 5-8 years of supervisory experience; strong communication, collaboration, and leadership skills. Preferred: ASQ CQA/CQE certifications and LEAN experience. High-Value: focus on bioprocessing, biologic manufacturing, ISO 9001 compliance, and quality culture development. Work Setup: on-site in Shrewsbury, MA, with leadership of multidisciplinary teams.