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 We Offer
- Competitive compensation
- Medical, dental, and vision coverage
- Tuition reimbursement
- Employee assistance and wellness programs
- Life and disability insurance
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.
