Principal Clinical Quality Assurance Specialist
About The Position
As a Principal Clinical Quality Assurance Specialist within the Pharmaceutical Quality System (PQS), you will serve as a subject matter expert in clinical vendor management, helping to ensure the quality, compliance, and audit readiness of clinical service providers. You will assess and qualify vendors, support global clinical audit programs, manage vendor files and systems, and play a critical role in inspection preparedness. This role supports the ongoing improvement of clinical vendor management procedures and fosters cross-functional alignment between Clinical, Sourcing, and Quality teams across Boston Scientific. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.
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.
- Prior experience working with Boston Scientific’s vendor management systems and processes.
Responsibilities
- Assess potential new vendors providing clinical services to ensure their capabilities meet quality and compliance expectations.
- 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.
- Write and revise vendor management procedures in collaboration with Clinical functional teams, Sourcing, and Clinical Supply Chain.
- 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.
- Review or audit study and validation activities and associated documentation for protocol, SOP, and GCP compliance.
- Issue audit certificates when appropriate and document findings through audit reports.
- Track audit findings and corrective actions to completion, maintaining full documentation in audit systems or databases.
- Contribute to or lead departmental SOP and work instruction development.
- Support or lead cross-functional projects to enhance clinical vendor oversight and compliance.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
