Senior Clinical Quality Associate

Senior Clinical Quality Associate
Role Summary
The Senior Clinical Quality Associate supports clinical affairs personnel globally in ensuring compliance with medical
device and GCP regulations and standards, as well as applicable company policies and procedures. This role spans
study support, CAPA management, and internal/external audit preparation and execution.
Key Responsibilities
Reviews study documents for compliance with applicable regulations, standards, and internal procedures.
Acts as a compliance resource to clinical study teams regarding applicable regulations, standards, and
procedures.
Supports compliant execution of clinical research projects.
Generates CAPA documentation including investigations, resolution plans, and implementation reports; drives
resolution cross-functionally.
Drives continuous process improvement and ensures work complies with regulatory and compliance standards.
Serves as a key player in preparation and overall support for internal and external audits, including responding to
audit findings through the CAPA process.
May perform internal compliance assessments and/or audits.
Supports project teams in preparation for regulatory authority inspections or audits.
May support additional clinical quality tasks as needed.
Required Qualifications
Bachelor's degree in a related field, or an equivalent combination of education and work experience.
Minimum 4 years of related work experience with a solid understanding of clinical quality or GCP compliance
functions.
Strong understanding of Good Clinical Practice (GCP) including U.S. regulations (21 CFR Parts 50, 54, 56, 812)
and international standards (ISO 14155).
Strong written communication skills and independent decision-making ability.
Effective problem-solving and planning skills; able to work independently under minimal supervision.
Preferred Qualifications
Minimum 5 years of experience in medical devices, clinical research, or a related industry.
Minimum 3 years in a quality role within a medical device or clinical trial environment.
GCP audit experience strongly preferred.