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.