Senior Quality Auditor
Listed on 2026-02-06
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, QA Specialist / Manager
West Leland Group is partnering with an established pharmaceutical manufacturing organization to hire a Senior Quality Auditor to support supplier qualification and oversight activities based in Greenville, SC.
This role focuses on supplier quality, risk-based auditing, and compliance within a cGMP-regulated pharmaceutical environment, working closely with internal stakeholders and external suppliers to ensure audit readiness and quality system compliance.
The ideal candidate is a supplier-focused Quality professional with strong GMP fundamentals who is comfortable traveling extensively and developing deeper audit ownership over time. This role is well suited for experienced auditors as well as Quality professionals ready to expand their scope into broader supplier oversight.
Location: Greenville, SC (on-site when not traveling)
Travel Expectations: Approximately 70%
What You’ll Do- Support supplier qualification activities in compliance with cGMP, GDP, and global regulatory requirements
- Maintain supplier qualification documentation including SAQs, Quality Agreements, Change Control Assessments, Risk Evaluations, Audit Reports, and CAPA responses
- Perform and participate in on-site supplier audits and document-based assessments
- Apply risk-based supplier criticality assessments to determine audit frequency and oversight
- Evaluate supplier data, documentation, and audit evidence for compliance with GMP, ISO, Annex I, and GLP requirements
- Review records for accuracy, consistency, and compliance with quality system expectations
- Prepare clear audit reports and support classification of findings as critical, major, or minor
- Follow up on audit findings and investigations through resolution and closure
- Partner with internal site teams to gather supplier-related information and support audit planning
- Maintain an organized audit and travel cadence
- Bachelor’s degree in a scientific or technical discipline or equivalent experience
- Quality Assurance experience within a GMP pharmaceutical manufacturing environment
- Experience supporting supplier quality activities, internal audits, or supplier qualification processes
- Strong understanding of data integrity principles, ALCOA, and quality systems
Ability to assess compliance risk and apply sound quality judgment - Strong written and verbal communication skills with the ability to produce clear audit documentation
- Comfortable working independently in a fast-paced, regulated environment
- Proficiency with Microsoft Office and electronic documentation systems
- CQA certification preferred but not required
- Opportunity to build depth in supplier quality and audit execution within a regulated pharmaceutical manufacturing environment
- Exposure to both internal and external audit activities
- Clear development runway for Quality professionals expanding audit scope and independence
- Competitive compensation and benefits within a stable, regulated organization
West Leland Group is a boutique search firm focused on Quality, Regulatory, and Medical Affairs roles for medical device, biotech, and pharmaceutical companies. With deep industry expertise and a long-term approach, we help innovative organizations build teams that drive better health outcomes. Thoughtful Search. Purposeful Hiring.
This search is being managed by West Leland Group on behalf of our client. West Leland Group is an equal opportunity search partner. Qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. This is a direct-hire position with a client company offering competitive compensation and benefits.
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