Strategic GMP Audit Lead — Quality & Compliance

Lonza Group Ltd.; Tampa (FL); Vor Ort; USD 90.000 - 140.000; Vollzeit

Zusammenfassung

Lonza Group Ltd. is seeking a Lead Auditing QA Specialist in Tampa, FL to oversee audit planning, execution, and reporting.

You will lead product and process audits, ensure GMP compliance, and collaborate with cross-functional teams to drive quality improvements and prevent issues. The role requires strong knowledge of GMP regulations, solid QA experience in pharma/biotech, and excellent communication and leadership skills.

Qualifikationen

• Strong understanding of GMP regulations and quality systems requirements for pharmaceutical manufacturing.
• Excellent written and verbal communication skills with internal and external stakeholders.
• Strong organizational skills and ability to manage multiple priorities in a fast-paced environment.

Aufgaben

• Lead audits of products and processes to ensure regulatory and internal standards compliance.
• Conduct opening and closing meetings, draft objectives, audit reports and final conclusions.
• Develop audit plans detailing objectives, scope, criteria and schedule.
• Select audit team based on audit complexity and required expertise.
• Ensure audits are conducted within timelines and resources are allocated efficiently.
• Lead interviews with key personnel at various levels of the organization.
• Represent the company in external audits and inspections.
• Identify areas for improvement and develop corrective action plans with cross-functional teams.
• Review audit findings to identify trends and areas of concern.
• Foster continuous improvement by promoting best practices in quality and compliance.

Kenntnisse

GMP regulations knowledge

Quality systems

Communication skills

Organizational skills

Stakeholder management

Ausbildung

Bachelor’s degree, science degree preferred

Jobbeschreibung

Lonza Group Ltd. is seeking a Lead Auditing QA Specialist in Tampa, FL to oversee audit planning, execution, and reporting.

You will lead product and process audits, ensure GMP compliance, and collaborate with cross-functional teams to drive quality improvements and prevent issues. The role requires strong knowledge of GMP regulations, solid QA experience in pharma/biotech, and excellent communication and leadership skills.