Senior QA Auditor: Lead Compliance & QMS Excellence

Clario; Pennsylvania; On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Competitive compensation

Medical, dental, and vision coverage

Tuition reimbursement

Employee assistance and wellness

Life and disability insurance

Job summary

Clario, part of Thermo Fisher Scientific, seeks a Senior Quality Assurance Auditor to lead diverse audits and strengthen the QMS. You will guide cross-functional teams to identify compliance risks, resolve quality events, and drive continuous improvement across the organization.

You will mentor colleagues, provide training, develop SOPs, and stay current with regulatory standards such as GCP, ICH, and 21 CFR Part 11.

Qualifications

• Associate's degree or equivalent in life sciences or quality-related field.
• Quality or quality systems certification (ASQ Auditor) or equivalent experience.
• 5+ years of QA/auditing/SDLC experience in a regulated industry (pharma/CRO/biotech/device).
• Strong knowledge of GCP, ICH Guidelines, 21 CFR Part 11/Annex 11 and electronic records regulations.

Responsibilities

• Plan, conduct, lead, and report audits (internal, external, vendor, customer, regulatory).
• Manage audit findings, CAPAs, root cause analyses, and effectiveness checks.
• Track audit activities, compliance reports, and quality metrics with management.
• Perform QA reviews of source documents, CRFs, reports, and validation deliverables.
• Collaborate with development and cross-functional teams to improve the audit program and QMS.
• Provide quality guidance and training; support root-cause analysis and mentoring.
• Develop or revise SOPs and maintain current regulatory knowledge through training.

Skills

QA auditing expertise

Leadership / mentoring

GCP/ICH/21 CFR knowledge

Written & verbal communication

Travel readiness

Education

Associate's degree or equivalent

ASQ Auditor certification or equivalent

Tools

Microsoft Word

Microsoft Excel

Job description

Clario, part of Thermo Fisher Scientific, seeks a Senior Quality Assurance Auditor to lead diverse audits and strengthen the QMS. You will guide cross-functional teams to identify compliance risks, resolve quality events, and drive continuous improvement across the organization.

You will mentor colleagues, provide training, develop SOPs, and stay current with regulatory standards such as GCP, ICH, and 21 CFR Part 11.