Sr Quality Assurance Auditor

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

What We Offer

• Competitive compensation
• Medical, dental, and vision coverage
• Tuition reimbursement
• Employee assistance and wellness programs
• Life and disability insurance

At Clario, a part of Thermo Fisher Scientific, the Senior Quality Assurance Auditor plays a key role in maintaining regulatory compliance and strengthening our Quality Management System (QMS). You will lead and support internal, external, vendor, customer, and regulatory audits while partnering with cross-functional teams to identify compliance risks, resolve quality events, and drive continuous improvement. This is an opportunity to apply your quality expertise while providing guidance and mentorship across the organization.

What You’ll Be Doing

• Plan, conduct, lead, and report internal, external, vendor/supplier, customer, registrar, and regulatory audits in accordance with applicable Standard Operating Procedures (SOPs) and electronic document management system processes.
• Manage and monitor audit findings, quality events, corrective and preventive actions (CAPAs), root cause activities, and effectiveness checks through timely closure, escalating significant quality concerns when appropriate.
• Track and trend audit activities, compliance reports, CAPAs, and quality metrics, communicating significant trends and risks to management.
• Perform Quality Assurance reviews of source documents, case report forms (CRFs), reports, and system development and validation deliverables for accuracy, consistency, and compliance.
• Partner with development and cross-functional teams to identify compliance risks, resolve quality issues, and implement process improvements, with particular focus on the audit program and Quality Management System.
• Provide quality-related guidance and training to colleagues, support root cause analysis, and mentor personnel as assigned.
• Develop or revise SOPs, support departmental and regulatory standards, and maintain current technical and industry knowledge through applicable training.

What We Look For

• Associate’s degree or equivalent required, preferably in life sciences, clinical trials, quality management, computer science, or a related field.
• Quality or quality systems certification, such as ASQ Auditor certification or auditor training, or equivalent experience.
• 5+ years of relevant experience in Quality Assurance, auditing, validation, and/or software development lifecycle (SDLC) systems within a regulated industry, preferably pharmaceutical, contract research organization (CRO), biotechnology, or medical device.
• Strong working knowledge of Good Clinical Practice (GCP), ICH Guidelines, software validation requirements, Quality Management Systems (QMS), 21 CFR Part 11, Annex 11, and applicable electronic records and electronic signatures regulations.
• Demonstrated leadership experience, including supporting, guiding, or mentoring colleagues.
• Strong problem-solving, documentation, organizational, interpersonal, and written and verbal communication skills, with the ability to manage multiple priorities and collaborate effectively across functions.
• Proficiency with common business software, including Microsoft Word and Excel; familiarity with medical and/or clinical trial terminology is desirable.
• Ability to travel up to 10% and lift up to 25 lbs.; this role may require extended periods of computer work.

At Clario, a part of Thermo Fisher Scientific, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.

Clario, a part of Thermo Fisher Scientific is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Clario Privacy Policy

Clario is a leading provider of endpoint data solutions to the clinical trials industry, generating high-quality clinical evidence for life sciences companies. We offer comprehensive evidence generation solutions that combine medical imaging, eCOA, precision motion, cardiac solutions and respiratory endpoints. For more than 50 years, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported over 30,000 clinical trials in more than 100 countries. Our global team of science, technology, and operational experts have supported over 70% of all FDA drug approvals since 2015.