Senior Supplier Quality Auditor

About the role

The Senior Supplier Quality Auditor plays a crucial role in ensuring compliance with regulatory requirements and internal procedures. This role involves leading audits of suppliers and external service providers, supporting supplier qualification and monitoring programs, and providing guidance and training on audit processes and GxP compliance.

Responsibilities

• Plan, schedule, and conduct onsite and remote audits of suppliers and external service providers in accordance with the approved supplier audit program.
• Evaluate supplier compliance with applicable regulatory requirements (e.g., FDA, EMA, ICH), internal SOPs, and executed quality agreements.
• Document supplier audit observations and collaborate with suppliers and internal stakeholders to develop appropriate and effective CAPAs.
• Track supplier CAPAs to closure and verify timely implementation and effectiveness.
• Maintain complete and accurate supplier audit records and ensure timely communication of audit results and risk assessments.
• Support regulatory inspections and inspection readiness activities related to supplier oversight and audit programs.
• Provide guidance and training to suppliers and internal teams on supplier audit processes and GxP compliance expectations.

Requirements

• Bachelor’s degree in Life Sciences, Chemistry, or a related field or equivalent experience.
• Minimum of 7 years of experience in quality assurance, auditing, or supplier management within the pharmaceutical, biotechnology, or cGMP industry.
• Auditing experience within regulated biotech/pharma industry or equivalent in a GxP-regulated environment, with at least 3 years in auditing or quality assurance.
• Strong knowledge of global GxP regulations and standards (e.g., 21 CFR Parts 11, 210, 211; EudraLex Volume 4; ICH Guidelines).
• Experience conducting audits across GMP, GLP, and/or GCP domains.
• Demonstrable ability to identify systemic quality and compliance risks.

Qualifications

• Proven ability to identify systemic quality and compliance risks.
• Excellent analytical, communication, and report-writing skills.
• Ability to work independently and manage multiple priorities.
• Ability to utilize AI tools to enhance individual productivity and quality of work.
• Strong technical writing skills for audit reports and regulatory documentation.