Senior Clinical QA Lead — Audits & Compliance

B Capital; Maple Grove (MN); Hybrid; USD 117,000 - 222,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific is seeking a Clinical Quality Assurance professional to act as QA representative on clinical project teams, promoting inspection readiness and overseeing audits of clinical systems, sites, and processes.

The role requires 5+ years in QA for clinical research, strong knowledge of GCP, ISO 14155/13485, GMP and GDP, and willingness to travel up to 30%. hybrid work model with location options in MA or MN.

Qualifications

• Bachelor's degree in science, engineering, health sciences or related discipline.
• Minimum of 5 years' experience in Clinical Quality Assurance or related quality function.
• Minimum of 5 years' experience conducting GCP audits, clinical research audits or other regulated quality audits.
• Working knowledge of ISO 14155, ISO 13485, GCP, GMP and GDP.
• Experience supporting quality systems, CAPA and regulatory compliance activities.
• Ability to travel up to 30%.

Responsibilities

• Serve as the Clinical Quality Assurance representative on clinical project teams, promoting a continuous state of inspection readiness.
• Plan, schedule and conduct internal and external quality assurance audits of clinical systems, investigative sites, processes and controls supporting clinical trials.
• Assess compliance with study protocols, GCP, applicable regulatory requirements and Boston Scientific policies and procedures.
• Evaluate the accuracy, integrity and quality of clinical data generated during clinical investigations.
• Communicate audit observations, evaluate responses, monitor corrective actions and ensure timely closure of audit findings.
• Support investigator sites during regulatory inspections, including preparation activities and responses to inspection findings.
• Contribute to the development and continuous improvement of Clinical QA processes, audit procedures and annual audit planning.
• Support clinical CAPA activities by partnering with CAPA owners and providing quality guidance.
• Represent Clinical Quality during acquisitions and integration activities by identifying risks, supporting sponsorship transfers and ensuring compliance with quality systems and regulatory requirements.
• Demonstrate a commitment to patient safety and product quality by maintaining compliance with the Boston Scientific Quality System and participating in internal quality and supplier audits.

Skills

GCP audits

Quality systems

CAPA

Regulatory compliance

GMP/GDP

GCP

Travel ability

Education

Bachelor's degree in science/engineering/health sciences

Job description

Boston Scientific is seeking a Clinical Quality Assurance professional to act as QA representative on clinical project teams, promoting inspection readiness and overseeing audits of clinical systems, sites, and processes.

The role requires 5+ years in QA for clinical research, strong knowledge of GCP, ISO 14155/13485, GMP and GDP, and willingness to travel up to 30%. hybrid work model with location options in MA or MN.