Principal Clinical Quality Assurance Specialist (Remote) 1 Job

Primary Location: [filter2]
Additional Locations: US-CA-Valencia; US-CO-Denver; US-FL-Orlando; US-GA-Atlanta; US-GA-Savannah; US-IL-Chicago; US-IN-Spencer; US-MA-Boston; US-MA-Marlborough; US-MN-Maple Grove; US-MN-Minneapolis; US-SC-Columbia
Requisition ID: 474196

Principal Clinical Quality Assurance Specialist

_ This position can be field based anywhere in the U.S. (Remote)_**

About the role:

Develops, establishes and maintains Clinical Quality Assurance programs, policies, processes, procedures and controls governing the Interventional Cardiology Clinical Function. Partners with Clinical trial teams to ensure the efficient and compliant implementation of the good clinical practices regulations/standards. Conducts clinical audits at investigator sites and clinical vendors.

Your responsibilities will include:

• Leads the clinical quality assurance team in the development of clinical audit procedures and processes.
• Subject matter expert on GCP regulations/standards in order to support the Clinical organization in meeting BSC Quality system requirements
• Plans, schedules, and conducts desktop vendor audits
• Plans, schedules and conducts desktop process/document audits
• Conducts investigator site audits
• Drives improvements in the clinical organization through the CAPA process, working cooperatively with Clinical NCEP/CAPA owners and Quality Manager providing quality input
• Leads annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives.
• Partners closely with Corporate clinical quality assurance group on cross-divisional initiatives
• Leads the preparation, coordination, and management of regulatory agency sponsor inspections
• Mentor CQA specialists with less experience and influence the quality culture across the IC Clinical organization

What we are looking for in you:

Minimal qualifications:

• Bachelor’s degree in Life Sciences and 7-10 years of experience
• Experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines
• Demonstration of BSC Core Values and growth mindset
• Up to 10-15% domestic and international travel required. Note: COVID-19 precautions currently restrict travel. At Boston Scientific, our priority is to protect and aid the health and safety of our employees, our physician customers, and their patients.

Preferred qualifications:

• Master’s degree in Life Sciences preferable
• Clinical QA and/or compliance experience preferred
• GCP auditing certification desired

Boston Scientific is an Equal Opportunity Employer.

Posting Notes: [filter2]||US-CA-Valencia; US-CO-Denver; US-FL-Orlando; US-GA-Atlanta; US-GA-Savannah; US-IL-Chicago; US-IN-Spencer; US-MA-Boston; US-MA-Marlborough; US-MN-Maple Grove; US-MN-Minneapolis; US-SC-Columbia||Quality||[mfield2]