Lead GMP QA Auditor & Audit Strategy Leader

Lonza Biologics, Inc.; Tampa (FL); On-site; Confidential; Full time

Job summary

Lonza Biologics, Inc. in Tampa, FL is seeking a Lead Auditing QA Specialist to plan and drive the audit program, review QMS, and identify risks requiring mitigation to assure GMP compliance. You will lead audit teams, draft objective-driven reports, and ensure documentation meets regulatory standards.

You will mentor junior auditors, collaborate with cross-functional teams, and represent Lonza in external audits and inspections to uphold product quality and safety.

Qualifications

• Bachelor’s degree in science required or equivalent experience.
• 5+ years in pharma/biotech QA, manufacturing operations or labs.
• Strong knowledge of GMP regulations and quality systems.
• Excellent written and verbal communication with stakeholders and suppliers.
• Good organizational skills and ability to manage multiple priorities.

Responsibilities

• Lead audits of products and processes to ensure compliance with regulations and standards.
• Conduct opening/closing meetings, draft objectives, and prepare evidence-based audit reports.
• Develop audit plans detailing objectives, scope, criteria, and schedule.
• Select audit team based on complexity and expertise.
• Ensure audits run on time and resources are allocated efficiently.
• Lead interviews with personnel at various levels and represent the company in audits.
• Identify improvements, develop action plans, and drive CAPAs with cross-functional teams.
• Review findings for trends and concerns, promoting best practices.

Skills

GMP compliance

Auditing leadership

Quality systems

Regulatory awareness

Effective communication

Documentation skills

Education

Bachelor’s degree in science

Job description

Lonza Biologics, Inc. in Tampa, FL is seeking a Lead Auditing QA Specialist to plan and drive the audit program, review QMS, and identify risks requiring mitigation to assure GMP compliance. You will lead audit teams, draft objective-driven reports, and ensure documentation meets regulatory standards.

You will mentor junior auditors, collaborate with cross-functional teams, and represent Lonza in external audits and inspections to uphold product quality and safety.