Senior Manager, Quality

Role Senior Manager, Quality responsible for strengthening quality systems, driving continual improvement, and fostering a quality-centric culture at the Marlborough site. Responsibilities oversee ISO 9001 compliance, internal/external audits, CAPA, document control, and validation lead and develop quality team members monitor quality metrics and KPIs support audit programs manage investigations and nonconformances lead digital transformation initiatives to transition to electronic systems collaborate with global quality stakeholders and site leadership to implement enterprise-wide quality processes promote continuous improvement and risk-based decision making Qualifications Bachelor's in Chemistry, Biology, Engineering, or related field 10+ years in regulated quality environments (ISO 9001, ISO 13485, cGMP) 4+ years of leadership experience in coaching and developing teams expertise in QMS, audits, CAPA, validation, and document control strong knowledge of GDP, root cause analysis, and quality investigations Preferred experience with digital quality system transformation, lean or operational excellence methodologies. High-value strategic quality leadership within biopharma manufacturing, supporting biologics or other biologic modalities, with a focus on compliance, continuous improvement, and digitalization. Work setup not specified, but involves cross-functional partnership and leadership. #J-18808-Ljbffr Repligen Corporation