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Principal Specialist, Corporate Clinical Quality Assurance
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About the position
The Corporate Clinical Quality Assurance (CQA) Principal Specialist will manage Corporate CQA activities in alignment with the strategies and goals set by Quality and Clinical leadership. This role plays a key part in ensuring the effectiveness of clinical quality systems and compliance with global regulatory standards through process improvement, oversight, and strategic collaboration.
Responsibilities
Collaborate with Quality and Clinical leadership to support the Clinical Trial Quality System subprocess, including continuous process improvements, maintenance of procedures in compliance with regulatory requirements, and mitigation of compliance risks.
Partner with Global Clinical Operations to ensure ongoing compliance of clinical research activities and to drive operational efficiency through process improvement initiatives and clinical systems.
Lead quality escalation discussions with global, cross-functional partners; drive and oversee non-conformances (NCEPs) and corrective/preventive actions (CAPAs); own CAPAs as needed.
Serve as a consultant on the interpretation of regulations and their application to clinical trial processes, translating them into practical, compliant quality system requirements.
Identify key areas of regulatory risk and propose resolutions to improve compliance with applicable regulations, BSC policies, and procedures.
Partner with divisional and regional Clinical Quality teams to gather data for management review presentations.
Support analysis of clinical metrics to identify trends and opportunities for improvement.
Support internal and external audits of Boston Scientific, as needed.
Review standard operating procedures (SOPs) to ensure compliance with regulations and BSC policies; lead SOP development when appropriate.
Lead project activities under the direction of Quality Management, including the development of project plans outlining work streams, timelines, roles, and resources.
Communicate project status, risks, and resolutions to management for key initiatives.
Foster cross-functional relationships to enable knowledge sharing, best practice adoption, and continuous improvement across the Clinical organization.
Promote a diverse and inclusive workplace that empowers all individuals to reach their full potential.
Requirements
Bachelor’s degree in Life Sciences, Engineering, or a related field
Minimum of 8 years' experience in Clinical Quality Systems, Clinical Operations/Project Management, or Regulatory Affairs
Medical device industry experience required
Extensive knowledge of FDA, ISO, EU MDR, and medical device quality requirements governing human subject research
Excellent organizational, execution, and communication skills
