Description:





Assists the Manager, CQA, with internal quality assurance program for the assigned studies within Neuromodulation, Neurovascular and Electrophysiology business units. Serves as clinical QA representative on clinical project teams, conducts internal and external CQA audits to assure that BSC clinical investigations comply with all applicable regulatory requirements and BSC policies and procedures. This position could be based out of either Fremont or Valencia, CA




Key Responsibilities




· Participates on clinical project teams providing GCP guidance.
· Plans, schedules, and conducts internal and external quality assurance audits of the systems, procedures, and controls employed in the design, conduct, and analysis of clinical trials.
· Assesses sponsor/investigator/monitor compliance with protocol and ICH/GCP requirements.
· Assesses the accuracy, validity, and quality of the scientific data generated during clinical trials.
· Documents audit observations; evaluates impact, and makes recommendations for corrective actions.
· Communicates observations to clinical investigators, clinical program managers, directors, and management.
· Evaluates responses to audit findings and ensures that appropriate corrective actions are completed.
· Participates in problem-solving at investigational sites.
· Works cross-functionally in identifying and resolving technical issues.
· Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.
· Supports departmental, functional, divisional, and corporate quality goals and priorities.
· Updates the audit database.
· Assists clinical QA Managers with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives.
· Develops new audit procedures and processes.
· Conducts BIMO Inspection Readiness training to study teams and BSC Clinical sites.
· Supports the preparation, coordination, and management of regulatory agency inspections of BSC offices.
· Assists with the preparation of investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings.




Quality Systems Duties and Responsibilities (if not already detailed above)




· Audits investigator sites for compliance with regulatory and SOP requirements.
· Provides training to Clinical Sciences and Clinical QA staff, as needed.
· Summarizes and analyzes data for trends.
· Reviews essential documents such as protocols, CRFs, and informed consent forms for adequacy and compliance with GCP and regulations.
· Engages, trains, and supervises contract auditors, as necessary.
· Builds quality into all aspects of work by maintaining compliance to all quality requirements.

Experience:
Qualifications




Minimum Education and Experience:
• BS/BA in Life sciences.
• Minimum 3 years’ experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines; 2 years’ clinical QA and/or compliance experience including Clinical auditing.
Working Conditions:
General office environment; up to 50 percent travel to investigator sites, meetings and other BSC facilities.





Boston Scientific is an Equal Opportunity Employer, EEO/AA