QA Analyst

Lonza - Newington, NH

Full-time - Manager

Newington, NH

Professional, Scientific, and Technical Services

About the position

The QA Manager, Inspections and Audit Management at Lonza is responsible for overseeing a team of Compliance Specialists and Project Managers. This role involves coordinating and executing internal audits, customer audits, and regulatory agency inspections to ensure compliance with GMP regulations. The manager will work closely with site leadership and customers to implement corrective actions and ensure the team is well-prepared for inspections. This position emphasizes the importance of quality management and continuous improvement within the organization.

Responsibilities

• Manage the internal audits and customer audits programs at the site.
• Ensure the audit team has the necessary knowledge and experience to perform audits and inspections.
• Coordinate responses to customer audits and regulatory inspections.
• Oversee the regulatory agency inspection program, ensuring readiness for GMP inspections.
• Manage inspection logistics and communications with corporate management and customers.
• Work with senior quality and site leadership to implement timely remediation actions.
• Provide direction and support to QA staff and act as a point of escalation.
• Maintain metrics relevant to the Inspection and Audit Management program and ensure continuous improvement.

Requirements

• Bachelor's degree in a relevant field; Regulatory Affairs preferred.
• 5-10+ years of experience in customer and regulatory auditing within FDA regulated industries.
• Advanced knowledge of GMP regulations including FDA 21 CFR 11, EMA, ICH, and other relevant standards.
• Excellent communication skills and strong interpersonal skills.

Nice-to-haves

• Experience with TrackWise and Microsoft Suite.
• Solid understanding of ERP Systems and Quality Management Systems.
• Detail-oriented and organized.

Benefits

• Opportunity to work in a meaningful role that impacts millions of lives.
• Supportive work environment that encourages creativity and problem-solving.