Company
pharmaceutical
SeniorPharmaceuticalQualityAuditor(GMP/MedicalDevice)
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Pharmaceutical Quality Auditor (GMP / Medical Device). Skills: Quality, audits, GMP, Medical Device, supplier audits, regulated manufacturing environments, quality standards, supplier quality systems, manufacturing controls, documentation, compliance practices, medical device quality systems, audit reports, corrective action review, supplier follow-up activities. Lead supplier audits in pharmaceutical and regulated manufacturing environments. Conduct audits to 21 CFR 210/211, EU GMP Vol. ”
What You'll Achieve.
Support corrective action review and supplier follow-up activities as needed
Industry & Context.
Willingness to travel throughout Southern California and surrounding regions, Availability to support a minimum of 2 audits per month, 1-2 Day Remote
What They're Looking For.
Must Have
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, experience with 21 CFR 210/211, EU GMP Vol. 4, and/or Canada GMP, Familiarity with ISO 13485 and/or 21 CFR 820, written and verbal communication skills, Willingness to travel throughout Southern California and surrounding regions, Availability to support a minimum of 2 audits per month
Nice to Have
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
What You'll Do.
Lead supplier audits in pharmaceutical and regulated manufacturing environments
Conduct audits to 21 CFR 210/211
and applicable quality standards
Assess supplier quality systems
manufacturing controls
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
How You'll Work.
Team & Collaboration
communicate findings to stakeholders; Represent SQA professionally at supplier sites and client engagements
Communication Scope
written and verbal communication skills
Full Job Description
## Key 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 ## Required Qualifications 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 ## Preferred Qualifications 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
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