Senior Clinical Quality Assurance Specialist

About This Role

This hybrid role supports a global Clinical organization in conducting investigational device trials worldwide. The specialist will serve as a clinical quality representative, provide compliance and regulatory consultation, and manage independent auditing to ensure adherence to quality standards and regulations.

Responsibilities

• Serve as the clinical quality representative on clinical trial project teams
• Provide clinical quality consultation and respond to compliance and regulatory questions
• Support the Inspection Readiness Program, including training and coordination of mock and external inspections
• Communicate with global clinical teams and Strategic Clinical Sourcing regarding clinical vendors
• Create risk-based study audit plans and conduct investigator site audits
• Document and communicate audit observations, evaluate impact, and recommend corrections
• Evaluate responses to audit findings and ensure appropriate corrective actions are completed
• Stay current on worldwide regulatory requirements and advise stakeholders on potential impacts
• Support divisional and global Clinical and Quality System teams during external regulatory audits
• Support the CAPA program by providing quality input for assessing internal noncompliance
• Participate in clinical and clinical quality continuous improvement initiatives
• Represent Clinical Quality on acquisition and integration teams, supporting risk identification and mitigation

Requirements

• Bachelor’s degree with a minimum of 8 years’ experience in medical device, pharmaceutical, or other GCP-regulated industry; or Associate degree in life sciences or nursing with active registered nurse licensure and a minimum of 8 years’ relevant experience
• Demonstrated clinical research audit experience or transferable experience suitable for rapid development into a clinical study or investigator site auditing role
• Demonstrated experience in a clinical quality and/or health care research compliance role
• Working knowledge of applicable regulations and standards, including GCP, Good Documentation Practices, and privacy and security requirements for human subject research (e.g., 21 CFR Parts 50, 54, 56, 812, and 11; EU MDR; ISO 14155:2020 and/or ICH E6; HIPAA; and GDPR)
• Strong verbal and written communication skills
• Ability to quickly learn and adopt quality system processes
• Strong proficiency with electronic systems, including understanding of user access controls and workflow validation processes
• Ability to travel domestically and internationally up to 30%

Qualifications

• Bachelor’s degree or Associate degree in life sciences or nursing with active registered nurse licensure
• Minimum of 8 years’ experience in medical device, pharmaceutical, or other GCP-regulated industry, or 8 years with Associate degree in life sciences/nursing

Nice to Have

• RAQP-GCP, SoCRA, ACRP, or equivalent certification
• Experience maintaining compliance within a medical device manufacturer quality system or other clinical quality system
• Experience interacting with regulatory authorities such as the U.S. FDA, EU competent authorities, Health Canada, PMDA, CFDA, or BfArM
• Minimum of 5 years’ direct clinical quality (GCP) auditing experience
• Knowledge of EU MDR requirements
• Demonstrated experience collaborating across complex, cross-functional teams