Senior QA Auditor: Lead Audits & QMS Improvement

eResearch Technology Inc; Philadelphia (Philadelphia County); On-site; USD 90,000 - 120,000; 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, a Thermo Fisher Scientific company, seeks a Senior Quality Assurance Auditor to lead diverse audits and strengthen our Quality Management System. You will partner with cross-functional teams to identify compliance risks, resolve quality events, and drive continuous improvement across regulatory standards.

The role requires 5+ years in QA/auditing within regulated industries, solid knowledge of GCP and 21 CFR 11, and strong leadership capabilities to mentor others.

Qualifications

• Associate’s degree or equivalent required.
• Quality or quality systems certification, such as ASQ Auditor certification or auditor training, or equivalent experience.
• 5+ years of QA, auditing, validation, and/or SDLC in a regulated industry (pharma/CRO/biotech/medical device).
• Strong knowledge of GCP, ICH Guidelines, 21 CFR Part 11, Annex 11, and electronic records/electronic signatures regulations.
• Demonstrated leadership experience and ability to mentor colleagues.
• Strong problem-solving, documentation, and communication skills across functions.
• Proficiency with Word and Excel; familiarity with clinical terminology is desirable.

Responsibilities

• Plan, conduct, lead, and report audits (internal, external, vendor, customer, registrar, regulatory).
• Manage and monitor audit findings, CAPAs, and closure of quality events.
• Track audit activities, compliance reports, CAPAs, and quality metrics; communicate risks to management.
• Perform QA reviews of source documents, CRFs, reports, and validation deliverables for compliance.
• Collaborate with development and cross-functional teams to identify risks and implement improvements.
• Provide quality guidance and training; mentor colleagues as assigned.
• Develop or revise SOPs and maintain current regulatory knowledge through training.

Skills

Quality Assurance

Auditing

SDLC

Leadership

Regulatory compliance

Documentation

Office proficiency

Education

Associate’s degree or equivalent

Tools

Microsoft Word

Microsoft Excel

Job description

Clario, a Thermo Fisher Scientific company, seeks a Senior Quality Assurance Auditor to lead diverse audits and strengthen our Quality Management System. You will partner with cross-functional teams to identify compliance risks, resolve quality events, and drive continuous improvement across regulatory standards.

The role requires 5+ years in QA/auditing within regulated industries, solid knowledge of GCP and 21 CFR 11, and strong leadership capabilities to mentor others.