Senior Clinical Quality Assurance Specialist

bostonscientific•Valencia, MN

14d•$85,000 - $161,500•Hybrid

About The Position

We are seeking an engaging and qualified Senior Clinical Quality Assurance Specialist who is aligned with Boston Scientific’s core values: caring, meaningful innovation, high performance, global collaboration, diversity, and winning spirit. A career with Boston Scientific is more than just a job — it’s personal. We are committed to solving some of health care’s toughest problems, united by a deep caring for human life. This hybrid role supports a global Clinical organization conducting investigational device trials at sites worldwide. If you are a natural problem solver with the imagination, courage, and drive to make a meaningful impact in clinical quality, this is an opportunity to build your career while advancing patient care. Qualified U.S.-based candidates are encouraged to apply. 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.

Requirements

Bachelor’s degree with a minimum of 8 years’ experience in the medical device, pharmaceutical, or other GCP-regulated industry; or Associate degree in life sciences or nursing with active registered nurse licensure and a minimum of 8 years’ relevant experience.
Demonstrated clinical research audit experience, or transferable experience suitable for rapid development into a clinical study or investigator site auditing role, such as clinical research associate or site monitor, clinical trial coordinator, GCP lead auditor, clinical CAPA lead, clinical research compliance professional, or clinical research SOP author.
Demonstrated experience in a clinical quality and/or health care research compliance role.
Working knowledge of applicable regulations and standards, including GCP, Good Documentation Practices, and privacy and security requirements for human subject research, such as 21 CFR Parts 50, 54, 56, 812, and 11; EU MDR; ISO 14155:2020 and/or ICH E6; HIPAA; and GDPR.
Independent, reliable, and professional team player aligned with Boston Scientific’s mission, vision, and culture.
Strong verbal and written communication skills, with the ability to engage diverse stakeholders and appropriately escalate complex or challenging issues when needed.
Ability to quickly learn and adopt quality system processes and adhere to organizational codes of conduct.
Strong proficiency with electronic systems, including understanding of user access controls and workflow validation processes.
Ability to travel domestically and internationally up to 30%.

Nice To Haves

RAQP-GCP, SoCRA, ACRP, or equivalent certification.
Experience maintaining compliance within a medical device manufacturer quality system or other clinical quality system.
Experience interacting with regulatory authorities such as the U.S. FDA, EU competent authorities, Health Canada, PMDA, CFDA, or BfArM.
Minimum of 5 years’ direct clinical quality (GCP) auditing experience.
Knowledge of EU MDR requirements.
Demonstrated experience collaborating across complex, cross-functional teams at all levels of the organization.

Responsibilities

Clinical compliance: Serve as the clinical quality representative on clinical trial project teams, bringing the voice of clinical quality and fostering a continuous state of inspection readiness.
Provide clinical quality consultation and respond to compliance and regulatory questions, including quality review of clinical study documents and related functional study plans.
Support the Inspection Readiness Program, including inspection readiness training and coordination and participation in mock BIMO inspections and external inspections.
Communicate with global clinical teams and Strategic Clinical Sourcing regarding clinical vendors, including new vendor requests, current needs, and future requirements.
Independent auditing: Create risk-based study audit plans and plan, schedule, and conduct investigator site audits; support internal clinical process audits and clinical vendor audits as needed to ensure compliance with regulatory requirements, quality standards, GCP, and Boston Scientific policies and procedures.
Document and communicate audit observations, evaluate impact, and make recommendations for corrections and corrective actions.
Evaluate responses to audit findings and ensure appropriate corrections and corrective actions are initiated and completed in a timely manner.
Stay current on worldwide regulatory requirements and advise stakeholders on potential impacts of regulatory changes.
Clinical quality system: Support divisional and global Clinical and Quality System teams during external regulatory and notified body audits.
Support the CAPA program by providing quality input for assessing internal noncompliance and recommending initiation of corrections and CAPAs, partnering closely with Clinical CAPA teams and owners through successful closure.
Participate in clinical and clinical quality continuous improvement initiatives and project teams.
Review and provide input on relevant Boston Scientific procedure revisions.
Support departmental, divisional, and corporate quality goals and priorities.
Acquisition integration: Represent Clinical Quality on acquisition and integration teams, supporting the identification, assessment, and mitigation of risks associated with the review and/or transfer of sponsorship of acquired clinical studies to ensure compliance with applicable ISO 14155 GCP standards and regional regulations.