Senior Supplier Quality Auditor

Job 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.
• Participate in continuous improvement initiatives related to supplier quality oversight and supplier audit processes.

Education And Experience

• 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.
• Minimum of 3 years of auditing or quality assurance experience within a GxP-regulated environment.
• 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.

Skills And 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.
• Sound quality judgment and ability to work independently.
• Strong communication and stakeholder management skills.

Work Environment

The noise level in the work environment is usually moderate. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.