Overview:
The Operations Quality Manager - Taunton is responsible for leading Quality Operations activities at the Taunton manufacturing facility, an ISO 9001 certified chemical manufacturing site. This role provides both strategic direction and hands-on oversight to ensure product quality, regulatory compliance, and continuous improvement throughout operations.
The manager will serve as the site Quality Process Owner, representing Taunton in global quality harmonization initiatives and acting as the primary liaison between site operations, global quality, and cross-functional teams across manufacturing, engineering, and validation.
Responsibilities:
* Manage and develop the Taunton Quality team, including quality engineers, technicians, and validation specialists.
* Define annual objectives, KPIs, and professional development goals for team members.
* Promote a strong culture of compliance, accountability, and continuous improvement throughout the site.
* Oversee finished product quality release, including batch record review and approval prior to shipment.
* Implement best practices in risk management, process capability, and Lean/Kaizen-based improvement initiatives.
* Partner with other manufacturing sites (Milford) & GDC (Franklin) to align quality processes and share best practices.
* Support new product introductions (NPI) and technology transfers as require.
* Support manufacturing with investigations, root cause analysis, and resolution of nonconformances.
* Lead Corrective and Preventive Actions (CAPA) to drive sustainable improvements in product and process quality.
* Maintain site compliance with ISO 9001 and corporate Quality Management System (QMS) requirements.
* Lead internal, external, and customer audits; ensure timely and effective closure of findings.
Qualifications:
* Bachelor's degree in Chemistry, Chemical Engineering, or another technical/scientific discipline is required; an advanced degree is preferred or equivalent experience
* Minimum 5 years of experience in Quality Assurance or related field within life sciences, medical device, or chemical manufacturing.
* Minimum 2-3 years of people leadership experience managing Quality or Operations.
* Strong understanding of ISO 9001, CAPA, internal audit, and validation systems.
* Proven success in cross-functional collaboration, process improvement, and problem-solving.
* Exceptional leadership, facilitation, and communication skills.
* Ability to work effectively across multiple organizations and manage complex priorities.
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