West Leland Group · 8 hours ago
Senior Quality Auditor
Greenville-Spartanburg-Anderson, South Carolina Area
Full-time
Onsite
Senior LevelWest Leland Group is partnering with an established pharmaceutical manufacturing organization to hire a Senior Quality Auditor. 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.
Staffing & Recruiting
Hiring Manager
Jack Feeley
Responsibilities
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
Qualification
Required
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
Preferred
CQA certification preferred but not required
Benefits
Competitive compensation and benefits
Company
West Leland Group
West Leland Group is a specialized search firm focused on Quality Engineering, Quality Systems, and Regulatory Affairs talent within the Medical Device industry.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase