Senior Clinical Quality Assurance Specialist

Additional Location(s): US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove About the role The Senior Clinical Quality Assurance Specialist assists the Manager, Clinical QA, in maintaining the internal quality assurance program for the assigned business area. This role serves as the Clinical QA representative on clinical project teams and conducts internal and external quality audits to ensure Boston Scientific clinical investigations comply with applicable regulatory requirements and company policies and procedures. Work model, sponsorship Hybrid work model requiring employees to be in the local office at least three days per week. This position does not offer visa sponsorship. Your responsibilities will include: Participate on clinical project teams and influence teams toward a continuous state of inspection readiness. Plan, schedule, and conduct internal and external quality assurance audits of systems, clinical investigative sites, procedures and controls employed in the design, conduct and analysis of clinical trials. Assess sponsor, investigator and monitor compliance with study protocols, Good Clinical Practice (GCP), applicable regulatory requirements and Boston Scientific policies and procedures. Assess the accuracy, validity and quality of scientific data generated during clinical trials. Participate in problem‑solving activities with project teams and investigator sites. Communicate audit observations to clinical investigators and clinical program managers. Document audit observations, evaluate the impact of audit findings, assess responses and ensure appropriate corrective actions are completed. Ensure audit findings are appropriately tracked through closure. Contribute to the development of audit procedures and processes. Assist Clinical QA managers with annual audit planning, review and trending of audit results and implementation of continuous improvement initiatives. Assist in preparing investigator sites for FDA and other regulatory agency inspections, including support for written responses to inspection findings. Stay current on worldwide regulatory requirements and advise management on the potential impact of regulatory changes. Support the Clinical organization in meeting Boston Scientific Quality System requirements. Support the CAPA process by partnering with Clinical NCEP/CAPA owners and providing quality assurance expertise. Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Boston Scientific Quality Policy and all documented quality processes and procedures. Ensure appropriate resources are maintained to support Quality System compliance. Promote a work environment that supports the Boston Scientific Quality Policy and Quality System. Qualifications Required qualifications: Bachelor's degree in science, health, engineering or a related field of expertise. Minimum of 3 years' experience with quality systems and controlled processes. Ability to travel up to 30%. Preferred qualifications: Working knowledge of ISO 14155 and Good Clinical Practice (GCP). Auditing experience in the medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines, or equivalent relevant experience. Working knowledge of U.S. and international regulations and standards applicable to Boston Scientific. Additional quality certifications, such as ASQ, SOCRA, RQAP‑GCP or equivalent. Experience working cross‑functionally with multiple stakeholders. Travel Ability to travel up to 30% of the time. Compensation Minimum Salary: $81,000 Maximum Salary: $153,900 EEO and Additional Requirements Boston Scientific Corporation is an equal opportunity employer. Recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to protected class characteristics. Certain U.S. based positions require acceptable proof of COVID‑19 vaccination status. Applicants may be notified that a vaccination requirement applies during the interview and selection process. COVID‑19 vaccination policies comply with applicable law and may be updated. For safety‑sensitive positions, candidates will be subject to a prohibited substance test as a requirement. #J-18808-Ljbffr Boston Scientific