Principal Clinical Quality Assurance Specialist

Recruiter: Spencer Gregory Hale

Principal Clinical Quality Assurance Specialist

About the role:

We are seeking an engaging and qualified Principal Clinical Quality Assurance Specialist to focuses on oversight and support of clinical research quality, with a strong emphasis on Good Clinical Practice (GCP). The role operates as both an independent auditor and a consultative quality partner to clinical teams. This individual will routinely assess compliance at clinical investigator sites (hospitals and institutions enrolling human subjects), as well as internally within Boston Scientific, ensuring regulatory expectations, internal procedures, and best practices are met. The role exists within a small, specialized clinical quality group that is distinct from broader design or manufacturing quality teams.

This is a high visibility hybrid position supporting a global Clinical team conducting investigational electrophysiology and cardiac rhythm management/diagnostic medical device studies at global sites. 

Your responsibilities will include:

Clinical Compliance: Hands-on partnership with Clinical for clinical quality consultation and inspection readiness:

• Provides clinical quality representation on clinical trial project teams to always foster and inspire clinical teams towards a state of inspection readiness
• Provides support and response to clinical quality, compliance and regulation questions including quality review of clinical study documents and related functional study plans
• Owns and/or supports management of internal clinical, external investigator site and clinical supplier nonconforming event management and CAPAs
• Supports Clinical Inspection Readiness program to include inspection readiness training and coordination, and participation in internal Mock BIMO inspections as well as external audits/inspections
• Communicates with internal stakeholders regarding clinical vendors, new clinical vendor requests, current clinical vendor needs, and future needs

Independent Auditing:

• Creates risk-based study audit plans; plans, schedules, conducts, provides internal oral debriefs and writes formal audit reports to internal stakeholders and leadership  for internal clinical quality audits, clinical process audits, investigator site audits, and clinical vendor audits to assure BSC clinical investigational pre-market, post-market and post approval  clinical studies comply with applicable regulatory requirements, quality and GCP standards, and BSC policies and procedures
• Documents evidence and provides rational and authoritative citations for audit observations of nonconformance; communicates audit observations; evaluates impact and makes recommendations for corrections and/or corrective actions. Evaluates responses to audit findings and ensures that appropriate corrections and corrective actions are timely initiated, documented and completed
• Keeps abreast of and interprets current worldwide regulatory requirements and good clinical practice standards; advises various stakeholders regarding possible ramifications of regulatory changes 

Clinical Quality System: Support to the Clinical organization in meeting BSC Quality system requirements:

• Demonstrate an unwavering commitment to patient safety and clinical quality by adhering to the Quality Policy and all documented processes and procedures, and maintaining a patient centric quality focus
• Supports Clinical and QS team during External Regulatory/Notified Body audits/inspections
• Supports the CAPA program, providing quality input for assessing internal noncompliance and recommending initiation of corrections/CAPAs, working closely with Clinical CAPA team and CAPA owners through to successful closure
• Participates in clinical process improvement projects and initiatives

• Provides reviews and comments in relevant BSC procedure revisions

• Supports departmental, divisional, and corporate quality goals and priorities 
• Initiates and/or collaborates on continuous improvement projects related to the BSC Clinical Quality Management System.

Acquisition integration:

• Represents Clinical Quality on clinical acquisition/integration teams for identification, assessment, and mitigation of risks associated with the transfer of sponsorship of clinical studies from acquired entities, supporting development and execution of a clinical integration plan, transfer of quality systems, and compliance to GCP and applicable regulations with aim to ensure subject safety and integrity of study data.

What we are looking for in you: 

Minimum Qualifications:

• Minimum of a bachelor’s degree in Science, Health, Engineering, or a related field with minimum of 8 years’ experience in the medical device, pharmaceutical, or other industry in an area regulated by GCP regulations and guidelines; OR in the alternative, a life science or Nursing Associate Degree with active Registered Nurse licensure and at least 10 years of relevant clinical research experience
• Demonstrated clinical research audit, compliance and related writing experience with one or more of the following: clinical trial primary research coordinator or monitor, GCP auditor, CAPA leader, research compliance auditor, clinical research SOP author, or equally relevant role

• Demonstrated experience in Clinical Quality Assurance and/or healthcare research compliance

• Working knowledge of regulations, standards, paper and electronic Good Documentation Practices, and privacy/security obligations relevant to conducting IDE Trials, including 21 CFR (50, 54, 56, 812, Part 11), GCP (ISO14155 and/or ICH E6), HIPAA and GDPR
• Independent, reliable, professional, collaborative, team player aligned with BSC mission, vision, and culture goals

• Demonstrated experience and critical thinking with complex verbal and written communication to a variety of stakeholders, as well as successful conflict resolution skills and strong presentation skills
• Strong electronic system adopter/user with understanding of system user access controls and workflow validations process
• Proficiency in MS Office apps WORD, Outlook, TEAMS, Excel, PowerPoint, SharePoint
• Ability to travel domestically and internationally up to 30%

Preferred Qualifications:

• RAQP-GCP/ SoCRA, CCRP, CHRC, or ACRP certification or equivalent
• Experience with maintaining compliance with medical device manufacturer quality system or other clinical quality system requirements
• US FDA, EU CA, Health Canada, PMDA, CFDA experience regarding clinical research, submissions and inspections
• 5 or more years of direct clinical quality (GCP) auditing experience
• Knowledge of EU MDR pertaining to clinical investigations of medical devices
• Demonstrated experience communicating with all levels of a complex organization

Requisition ID: 621952 

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.

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.

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.