Senior GMP Audit Lead - Quality & Compliance

Lonza; Tampa (FL); On-site; USD 110,000 - 150,000; Full time

Job summary

Lonza in Tampa, FL is seeking a Lead Auditing QA Specialist to oversee the audit program aligned with GMP requirements. You will plan, execute and lead audits of products and processes, draft objective scopes, and deliver evidence-based reports.

Collaboration with cross-functional teams to implement CAPA and improve compliance is essential. You will mentor junior auditors, participate in external inspections, and ensure audits are completed on schedule while upholding Lonza's quality standards

Qualifications

• 5+ years of experience in manufacturing operations, laboratory operations and/or QA.
• Strong understanding of GMP regulations and quality systems requirements for pharmaceutical manufacturing.
• Excellent written and verbal communication skills with the ability to interact effectively with internal stakeholders and external suppliers
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines in a fast-paced environment

Responsibilities

• Lead audits of products and processes for compliance with regulations and standards.
• Conduct opening and closing meetings, draft objectives, evidence-based audit reports, and determine final compliance conclusions.
• Develop an audit plan detailing objectives, scope, criteria, and schedule.
• Lead audit teams based on complexity and required expertise.
• Ensure audits are conducted within timelines and resources are allocated.
• Represent the company in external audits and inspections.
• Identify areas for improvement and develop action plans to address them.
• Collaborate with cross-functional teams to implement corrective and preventive actions.
• Mentor junior auditors and independently write SOPs or related documentation.
• Participate in investigations into root cause and CAPA impacts on product safety and quality.

Skills

GMP compliance knowledge

Quality systems

Strong communication skills

Organizational skills

Stakeholder interaction

Job description

Lonza in Tampa, FL is seeking a Lead Auditing QA Specialist to oversee the audit program aligned with GMP requirements. You will plan, execute and lead audits of products and processes, draft objective scopes, and deliver evidence-based reports.

Collaboration with cross-functional teams to implement CAPA and improve compliance is essential. You will mentor junior auditors, participate in external inspections, and ensure audits are completed on schedule while upholding Lonza's quality standards