Senior QA Auditor Radiopharmaceuticals (On-Site)

We are seeking an experienced Senior QA Auditor with a strong background in Radiopharmaceuticals (RPT) to join our quality assurance team. This role plays a critical part in ensuring compliance with cGMP, GDP, FDA, EMA, and ICH regulatory standards while supporting the Pharmaceutical Quality System (PQS) through proactive auditing and continuous improvement initiatives.

The ideal candidate is a detail-oriented professional with hands-on experience conducting internal and external audits across manufacturing, testing, and distribution operations.

Key Responsibilities

• Plan, conduct, and report on internal, external, and risk-based audits of RPT CMOs, suppliers, and internal processes.
• Develop comprehensive audit plans, checklists, and schedules in alignment with regulatory and company standards.
• Ensure strict adherence to FDA, EMA, ICH , and other relevant global compliance frameworks.
• Review and approve deviations, CAPAs, and change controls , ensuring effective closure and documentation.
• Issue detailed audit reports and maintain oversight of CAPA implementation and verification.
• Guide operational teams on audit readiness and compliance requirements .
• Support regulatory inspections and customer audits , ensuring seamless coordination and documentation.
• Identify systemic quality issues and contribute to the development of process improvement initiatives .
• Stay informed on evolving global quality and regulatory standards to maintain audit program effectiveness.

Qualifications (Must Have)

• Bachelor's degree in Life Sciences, Pharmacy, or a related discipline .
• 35 years of experience in Radiopharmaceuticals , with a minimum of 2 years in auditing .
• In-depth knowledge of RPT cGMP, GDP , and global regulatory requirements .
• Proven ability to plan, execute, and report audits independently.
• Strong analytical, organizational, and report-writing skills .
• Excellent communication skills and attention to detail.
• Ability to travel up to 10% for audits and inspections.

Preferred / Nice to Have

• ASQ Certified Quality Auditor (CQA) .
• ISO 9001 Lead Auditor Certification .
• GCP/GMP Auditing Certifications or equivalent industry credentials.

Core Competencies & Technical Skills

cGMP | GDP | FDA | EMA | ICH | RPT cGMP
Regulatory Inspections | Customer Audits | CAPA | Deviations | Change Controls
Audit Planning | Checklists | Scheduling | Reporting | Process Improvements
Compliance Requirements | Audit Readiness | Report Writing | PQS | ISO 9001
Excellent Analytical & Communication Skills