Principal Clinical Quality Assurance Specialist

Additional Location(s): US-MA-Marlborough; US-CA-Valencia; US-IN-Spencer; US-MN-Arden Hills; US-MN-Maple Grove

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:
The Principal Clinical Quality Assurance Specialist assists with internal quality assurance program for the assigned business area.  Serves as clinical QA representative on clinical project teams and conducts internal and external quality audits to assure that BSC clinical trials comply with all applicable regulatory requirements and BSC policies and procedures. Supports Inspection Readiness, Clinical Corrective and Preventative Action (CAPA) and acquisition integration. 

Your responsibilities will include:

• Support clinical project teams and always influences them toward a state of inspection readiness.
• Create risk-based study-specific audit plans; plan, schedule, and conduct investigator site audits per the study audit plan to ensure study conduct at the audited site complies with applicable Regulations and Good Clinical Practice standards
• Document and communicate audit observations to internal BSC stakeholders; evaluate impact and make recommendations for corrections and/or corrective actions.
• Evaluate responses to audit findings and ensure that appropriate corrections and corrective actions are timely initiated and completed, and audits are appropriately closed
• Assess sponsor/investigator/monitor compliance with protocol, GCP and applicable regulatory requirements and relevant BSC policies and procedures.
• Assess the accuracy, validity, and quality of the clinical trial data.
• Documents audit observations; evaluates impact and responses to audit findings and ensures the appropriate corrective actions are completed.
• Contribute to the development of audit procedures and processes.
• Support the preparation, coordination, and management of regulatory agency sponsor inspections of BSC offices.
• Assist in preparation of investigator sites for FDA or other regulatory agency inspections.
• Keep abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.
• Support to the Clinical organization in meeting BSC Quality system requirements.
• Support the CAPA process, working cooperatively with Clinical NCEP/CAPA owners.
• Support clinical integration teams of acquisitions to ensure development and execution of the clinical integration plan.
• Support clinical teams in gathering and reporting various performance metrics for quarterly BU Management Review meetings. 

What we are looking for:

Required Qualifications:

• Bachelor’s degree in Life Sciences and 7-10 years of experience in the medical device, pharmaceutical, or other industry regulated by good clinical practice.
• Demonstrated experience in Clinical Quality Assurance and/or healthcare research compliance
• Familiarity with Regulations and GCP standards for conducting IDE Trials, including 21 CFR (50, 54, 56, 812, Part 11), GCP (ISO14155:2020 and/or ICH E6 R2), HIPAA and/or GDPR, paper and electronic Good Documentation Practices
• Independent, reliable, professional, collaborative, team player aligned with BSC mission, vision, and culture goals
• Demonstrated experience with complex verbal and written communication to a variety of stakeholders. 
• Effective communication skills to understand divergent cross-functional stakeholder priorities and opinions while supporting/ensuring Quality goals.
• Strong electronic system adopter/user with understanding of system user access controls and workflow validations process
• Ability to travel domestically and internationally up to 30%

Preferred qualifications:

• Master’s degree in Life Sciences preferred
• RQAP-GCP, SoCRA, CHRC or ACRP certification or equivalent
• Demonstrated clinical research auditing experience with one or more of the following proficiencies: clinical research primary coordinator, site monitor, IRB or facility clinical quality representative, GCP educator, clinical research CAPA leader, clinical research compliance team member, or other applicable clinical research role
• FDA, EU CA, Health Canada, PMDA, CFDA, BfArM experience 

 

This position can be worked hybrid from the follo