QA Analyst

Lonza - Portsmouth, NH

Full-time - Manager

Portsmouth, 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/Project Managers to coordinate and complete internal audits, customer audits, and regulatory agency inspections. This role involves working closely with site leadership and customers to implement corrective and preventive actions in response to deficiencies, ensuring the site is prepared for inspections and audits. The manager will also provide training, coaching, and performance evaluations for the team, while maintaining metrics relevant to the Inspection and Audit Management program.

Responsibilities

• Manage the internal audits and customer audits programs at the site.
• Ensure the audit team has the appropriate knowledge, education, and experience to handle the audit schedule and perform internal audits.
• Coordinate and support execution of responses to customer audits and inspections.
• Own the regulatory agency inspection program for the site, ensuring readiness for routine GMP inspections and pre-approval inspections.
• Run inspection logistics and communications to site, corporate management, and customers.
• Work with senior quality and site leadership to identify and implement remediation in a timely manner.
• Provide general direction and support, acting as a point of escalation for QA staff and customers.
• Support the flow of tasks to ensure deliverables are met.
• Provide updates on audit program metrics, improvements, issues, and endorsements as a member of the site Quality Council.
• Attend CAPA board meetings and maintain metrics relevant to the Inspection and Audit Management program.

Requirements

• Bachelor's degree in a relevant field; Regulatory Affairs preferred.
• Minimum 5-10+ years of experience in customer and regulatory auditing within FDA regulated industries.
• Advanced knowledge of relevant GMP regulations: FDA 21 CFR 11, EMA, ICH, and other relevant regulations and standards.
• Excellent communication skills.
• Strong interpersonal skills to interact with clients, team members, and regulatory agencies.

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 people.
• Supportive work environment that encourages creativity and problem-solving.