Principal Clinical Quality Assurance Specialist

Boston Scientific • Maple Grove, MN

1d

About The Position

Your responsibilities will include: Participate in or lead vendor audits to determine qualification status and compliance with GCP and regulatory requirements. Prepare, maintain, and manage the global Clinical Approved Vendor List (cAVL) for PQS. Support regulatory inspection readiness by ensuring documentation and vendor assessments are complete and audit-ready. Investigate clinical vendor quality issues and assist in developing or reviewing corrective action plans. Contribute to or lead departmental SOP and work instruction development. Support or lead cross-functional projects to enhance clinical vendor oversight and compliance.

Requirements

• Minimum of a bachelor's degree, or an associate degree with a minimum of 7 years' professional experience.
• Minimum of 5 years' auditing experience in a regulated industry.
• Experience working in FDA-regulated environments such as medical devices, pharmaceuticals, or biologics.
• Experience in Clinical Quality Assurance or other Clinical or Quality-related roles.
• Willingness and ability to travel up to 25-30% domestically and internationally, as needed.

Nice To Haves

• Bachelor's degree with a minimum of 7 years' professional experience conducting vendor audits.
• Experience working in vendor quality roles across multiple sectors (e.g., pharmaceuticals, biologics, medical devices).
• Direct experience with Clinical Quality, including oversight of CROs and other clinical service providers.

Responsibilities

• Participate in or lead vendor audits to determine qualification status and compliance with GCP and regulatory requirements.
• Prepare, maintain, and manage the global Clinical Approved Vendor List (cAVL) for PQS.
• Support regulatory inspection readiness by ensuring documentation and vendor assessments are complete and audit-ready.
• Investigate clinical vendor quality issues and assist in developing or reviewing corrective action plans.
• Contribute to or lead departmental SOP and work instruction development.
• Support or lead cross-functional projects to enhance clinical vendor oversight and compliance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees