Principal Clinical Quality Assurance Specialist

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

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

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 your ambitions.           

About the role:

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.

Work model, sponsorship, relocation:

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.

Your responsibilities will include:

• 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.

Qualifications:

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.

Preferred qualifications:

• 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 ID: 623678 

Minimum Salary: $ 102100 

Maximum Salary: $ 194000 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—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, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.