Delivering on the promise of medical innovation begins at Boston Scientific.
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Sr Clinical Quality Assurance Specialist
Description
Delivering on the promise of medical innovation begins at Boston Scientific
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Assists the Manager, CQA, 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 investigations comply with all applicable regulatory requirements and BSC policies and procedures.
Responsibilities
• Participates on clinical project teams.
• 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 GCP/ICH 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.
• Keeps abreast of current worldwide regulatory requirements.
• Supports departmental, functional, divisional, and corporate quality goals and priorities.
• Updates the audit database.
• Assists with preparation of, coordination, and management of regulatory agency inspections of BSC offices.
• Assists with preparation of investigator sites for FDA or other regulatory agency inspection.
• Performs vendor assessment audits prior to contract initiation.
• Reviews essential documents such as protocols, CRFs, and informed consent forms for adequacy and compliance with GCP and regulations.
• Audits investigator sites for compliance with regulatory and SOP requirements.
• Builds quality into all aspects of work by maintaining compliance to all quality requirements.
Qualifications
Minimum Education and Experience:
• Life sciences degree.
• Two years’ experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines; 1 year of clinical QA and/or compliance experience; 1 year of auditing experience.
** This position could be remotely based***
