Senior Quality Assurance Auditor – Regulatory Compliance Leader

Clario; Philadelphia (Philadelphia County); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Tuition reimbursement

Employee assistance and wellness

Life and disability insurance

Competitive compensation

Job summary

Clario, part of Thermo Fisher Scientific, seeks a Senior Quality Assurance Auditor to lead audits across internal, external, vendor, and regulatory domains. You will mentor teams, identify compliance risks, and drive improvements within the Quality Management System.

You will apply GCP/ICH knowledge and QA expertise to ensure accuracy of documents, CAPAs, and quality metrics, while collaborating with cross-functional groups to uphold regulatory standards.

Qualifications

• Associate's degree or equivalent required.
• Quality or quality systems certification (e.g., ASQ Auditor) or equivalent experience.
• 5+ years of relevant experience in Quality Assurance, auditing, validation, and/or SDLC within regulated industry.

Responsibilities

• Plan, conduct, lead, and report internal, external, vendor/supplier, customer, registrar, and regulatory audits.
• Manage and monitor audit findings, CAPAs, root cause activities, and effectiveness checks.
• Track and trend audit activities, compliance reports, CAPAs, and quality metrics; communicate risks to management.
• Perform QA reviews of source documents, CRFs, reports, and validation deliverables for accuracy and compliance.
• Partner with cross-functional teams to identify risks and implement process improvements for the audit program and QMS.
• Provide quality-related guidance and training to colleagues and mentor personnel.
• Develop or revise SOPs and maintain current regulatory standards.

Skills

GCP & ICH Guidelines

Leadership & mentoring

Strong communication

Education

Associate's degree or equivalent

Tools

Microsoft Word

Excel

QMS software

Job description

Clario, part of Thermo Fisher Scientific, seeks a Senior Quality Assurance Auditor to lead audits across internal, external, vendor, and regulatory domains. You will mentor teams, identify compliance risks, and drive improvements within the Quality Management System.

You will apply GCP/ICH knowledge and QA expertise to ensure accuracy of documents, CAPAs, and quality metrics, while collaborating with cross-functional groups to uphold regulatory standards.