Director, Quality Operations

Lonza • Portsmouth, NH

3d • Onsite

About The Position

Director, Quality Operations Location: On-site, Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed. The Director of Quality Operations provides strategic leadership for GMP compliance within customer-dedicated manufacturing areas, ensuring adherence to global quality standards and regulatory requirements. As a senior leader, they drive continuous improvement initiatives, foster a strong culture of quality awareness, and collaborate across departments to align on quality performance . This role directly manages quality staff, overseeing operational support, batch records, and lot release activities. They serve as the primary customer liaison, participating in Joint Quality Steering Committees to ensure expectations are met. Additionally, the incumbent manages resource allocation, staff development, and high-level decision-making for site escalations . What you will get: Competitive salary and comprehensive benefits package Opportunities for career development and internal mobility Supportive and inclusive work environment Access to cutting-edge technologies and resources Flexible working arrangements where applicable Commitment to employee well-being and safety Collaborative culture that values innovation and excellence Access to our full list of global benefits: https://www.lonza.com/careers/benefits

Requirements

• Bachelor's degree in Life Sciences or equivalent experience
• 5-10 of QA experience with proven leadership skills
• Experience leading and managing direct reports with demonstrated coaching and mentoring capabilities
• Advanced knowledge of GMPs and regulations
• Demonstrated quality and strategic decision making skills

Nice To Haves

• Experience participating in, or leading, Domestic and International Regulatory Inspections preferred
• Experience in Corporate Quality System initiatives (Six Sigma, Lean, etc.) a plus.

Responsibilities

• Strategic Leadership: Develop and implements the overall quality strategy across manufacturing operations.
• Compliance Assurance: Ensure operational compliance with Customer Quality Agreements, SOPs, and regulatory requirements.
• Quality Management & Risk Resolution: Lead investigation of high-risk deviations, CAPA, and change controls in partnership with cross-functional teams.
• Audit & Inspection Support: Support customer audits and regulatory inspections.
• Metrics & Reporting: Track Key Performance Indicators (KPIs) and presents deviation trends to senior management.
• Lot Disposition: Execute final lot release and quality approval processes.
• Team Leadership & Mentoring: Manage staff, conducts 1-on-1s, and mentors staff to drive continuous improvement and career development

What This Job Offers

• Job Type: Full-time
• Career Level: Director