Principal Clinical Quality Assurance Specialist

Principal Clinical Quality Assurance Specialist

Onsite Location(s):
Maple Grove, MN, 55311

Additional Location(s): US-MN-Maple Grove;
Ireland-Cork; US-MA-Marlborough

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit
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At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high‑performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever yourn

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, 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. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

• 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.

Required qualifications:

• 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.

• 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.

Requisition

Minimum Salary: $102,100

Maximum Salary: $194,000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see  – will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training,…