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.