QA Operations Lead - Batch Records

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Career growth opportunities

Leadership development

Collaborative cross-functional culture

Competitive compensation

Job summary

Lonza in Portsmouth, NH is seeking a QA Manager - Operations to lead a high-performing batch record review team and ensure compliant release of biologics manufacturing outputs. You will drive quality decisions, risk assessments, and cross-functional collaboration to support on-time delivery of therapies.

You will mentor QA staff, partner with Manufacturing, QC, and MSAT, and shape quality strategy while maintaining inspection readiness and continuous improvement across the site.

Qualifications

• Bachelor’s degree in a scientific discipline required.
• 5–10 years QA experience in GMP-regulated environment.
• Experience leading and developing staff and cross-functional partners.

Responsibilities

• Lead QA Operations Batch Record Review and release support.
• Mentor and develop QA reviewers and manage workload.
• Provide guidance on deviations, CAPAs, investigations, and change controls.
• Collaborate with Manufacturing to resolve observations and ensure compliant docs.
• Support batch disposition and regulatory inspections readiness.
• Drive continuous improvement and QA strategy across operations.

Skills

QA Leadership

GMP Knowledge

Stakeholder Management

Decision Making

Analytical Thinking

Education

Bachelor’s degree in a scientific discipline

Tools

TrackWise

SAP

Syncade

MS Office

Job description

Lonza in Portsmouth, NH is seeking a QA Manager - Operations to lead a high-performing batch record review team and ensure compliant release of biologics manufacturing outputs. You will drive quality decisions, risk assessments, and cross-functional collaboration to support on-time delivery of therapies.

You will mentor QA staff, partner with Manufacturing, QC, and MSAT, and shape quality strategy while maintaining inspection readiness and continuous improvement across the site.