Senior Supplier Quality Auditor

• 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.

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.

Core Competencies

Demonstrates expertise in conducting supplier audits and ensuring compliance with GxP regulations, including FDA and EMA standards. Proficient in developing CAPAs and maintaining audit records while providing training and guidance on quality assurance processes.

Highest-signal resume keywords

• Supplier Auditing


• GxP Compliance


• CAPA Development


• Quality Assurance


• Regulatory Knowledge

ATS Optimization Keywords

Hard Skills

• Auditing


• Quality Assurance


• Regulatory Compliance


• GMP


• GLP


• GCP


• CAPA Management


• Risk Assessment


• Document Management


• Continuous Improvement

Soft Skills

• Collaboration


• Communication


• Training


• Problem-Solving


• Stakeholder Engagement

Industry Keywords

• Pharmaceutical


• Biotechnology


• CGMP


• FDA


• EMA


• ICH Guidelines


• 21 CFR


• EudraLex


• Quality Agreements


• SOPs