Senior Pharmaceutical Quality Auditor (GMP / Medical Device)

SQA Services • Los Angeles, CA

2d • Hybrid

About The Position

SQA Services is seeking a Senior Pharmaceutical Quality Auditor to support ongoing supplier audits throughout Southern California and surrounding regions. This role requires a highly experienced auditor with a strong background in pharmaceutical GMP auditing, including experience leading external supplier audits independently. The ideal candidate will be located near a major transportation hub in Southern California and willing to travel to support a minimum of 2 audits per month.

Requirements

• 15+ years of experience in Quality within pharmaceutical or regulated industries
• Minimum 5+ years performing audits as a lead auditor
• Experience conducting external supplier audits independently
• Strong experience with 21 CFR 210/211, EU GMP Vol. 4, and/or Canada GMP
• Familiarity with ISO 13485 and/or 21 CFR 820
• Strong written and verbal communication skills
• Willingness to travel throughout Southern California and surrounding regions
• Availability to support a minimum of 2 audits per month
• Must be a U.S. citizen or U.S. lawful permanent resident (green card holder) to comply with ITAR regulations.

Nice To Haves

• Experience with ISO 17025 (Laboratories)
• Experience auditing packaging (ISO 15378), warehousing/distribution, excipients, or APIs
• Additional experience with Food or Animal Health standards (21 CFR 110, 111, 120, or 507)
• Located near Los Angeles or another major Southern California transportation hub

Responsibilities

• Lead supplier audits in pharmaceutical and regulated manufacturing environments
• Conduct audits to 21 CFR 210/211, EU GMP Vol. 4, Canada GMP, and applicable quality standards
• Assess supplier quality systems, manufacturing controls, documentation, and compliance practices
• Support audits involving medical device quality systems (ISO 13485 / 21 CFR 820)
• Prepare detailed audit reports and communicate findings to stakeholders
• Represent SQA professionally at supplier sites and client engagements
• Support corrective action review and supplier follow-up activities as needed

Benefits

• Travel expenses reimbursed at cost with receipts per SQA travel policy.
• Flexible, project-based opportunity — you may accept or decline audit assignments based on your schedule.

What This Job Offers

• Career Level: Senior
• Education Level: No Education Listed