Senior Global QA Auditor – Sterile Pharma Manufacturing

• Lead internal audits across multiple manufacturing sites; support CAPA definition followup and closure.
• Conduct external audits of CMOs API manufacturers laboratories material suppliers medical device partners logistics providers and clinical service organizations.
• Prepare and execute annual audit plans; assess new audit requests; prepare audit reports and track action plans.
• Identify and escalate compliance risks with potential business or reputational impact; advise stakeholders on remediation strategies.
• Participate in and mentor colleagues within the PartTime Lead Auditor (PTLA) program.
• Act as a subject matter expert during customer audits and regulatory inspections.
• Support supplier surveillance activities including quality requirement definition and procedure development.
• Contribute to global quality initiatives regulatory trend assessments and crosssite gap consolidation.

• Strong background in aseptic/sterile manufacturing covering both APIs and finished dosage forms.
• Solid understanding of EU GMP Annex 1 and sterile manufacturing principles.
• Proven experience leading GMP audits (internal and external).
• Ability to perform solo audits and manage complex situations independently.
• Flexibility and resilience: approx. 2025 audits per year with 50% international travel (Europe India China Southeast Asia Africa US).
• Excellent command of English.
• Balanced collaborative personality able to integrate into a small senior team without hierarchical tendencies.
• Permanent residency in Hungary or willingness to relocate.

• A highvisibility position within a global Corporate Quality function.
• Close collaboration with experienced principal auditors in a small expert team.
• Significant autonomy and global exposure across diverse manufacturing and supplier environments.
• Opportunity to shape compliance standards in a highly regulated sterilefocused Global Lead Auditor

Required Experience:

Senior IC