Specialist, Prin Clin QA
Recruiter:
Spencer Gregory HalePrincipal Specialist, Corporate Clinical Quality AssuranceDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.
With access to the latest tools, information and training, we'll help you in advancing your skills and career.
Here, you'll be supported in progressing - whatever your ambitions.
About the role:
The Corporate Clinical Quality Assurance (CQA) Principal Specialist will help manage select Corporate CQA activities in line with strategies and goals set by Quality and Clinical management.
Ensures clinical research activities conform to federal and international standards and BSC processes and expectations.
This role will help drive the implementation of Quality Management-approved solutions to ensure compliance through effective, efficient, and sustainable processes.
Key responsibilities include:
Work with Quality and Clinical Stewards and senior management to support maintenance of the Product Approval - Clinical Trial quality system subprocess including process improvements, maintenance of procedures to regulatory requirements, and addressing compliance risks.
Collaborate with Global Clinical Operations to ensure ongoing compliance of clinical research activities and operational efficiency through support of CAPAs, process improvement initiatives, and clinical systems.
Acts as a consultant relative to the interpretation of regulations and their impact on Clinical trial processes and implementation of new QS requirements.
Help identify key areas of regulatory risk and suggest potential resolutions as well as ways to improve compliance to regulations and BSC policies and procedures.
Partner with divisional/regional Clinical Quality teams to gather data for management reviews.
Support analysis of Clinical metrics to identify opportunities for improvement Support internal and external audits of BSC, as needed.
Review BSC policies and procedures to ensure compliance with external and internal requirements.
Contribute as SME to the development and maintenance of BSC policies and procedures, as needed.
Lead project activities, as needed, under the direction of Quality Management.
Develop project plans outlining work plans, timelines, roles and resources.
Communicate status, risks, and resolutions to management on key initiatives.
Create relationships across the business that enable sharing of knowledge, best practices, and solutions that can be leveraged across Clinical.
Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
5-10% potential domestic travel What we're looking for in you:
Minimum
Qualifications:
Bachelor's degree in Life Sciences, Engineering, or related field Minimum of 7 years of Clinical Quality Systems, Clinical Operations/Project Management, or Regulatory Affairs experience Medical device industry experience required Knowledge of international standards, regulations and guidelines governing human subject research (ISO 14155, CFRs, EU MDR, MDCG Guidance, etc.
) Requisition ID:
565883Among other requirements, Boston Scientific maintains specific drug testing requirements for safety-sensitive positions.
This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a requirement.
The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
Recommended Skills Business Efficiency Business Process Improvement Clinical Research Clinical Trials Clinical Works Human Subject Research Estimated Salary: $20 to $28 per hour based on qualifications.
Spencer Gregory HalePrincipal Specialist, Corporate Clinical Quality AssuranceDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.
With access to the latest tools, information and training, we'll help you in advancing your skills and career.
Here, you'll be supported in progressing - whatever your ambitions.
About the role:
The Corporate Clinical Quality Assurance (CQA) Principal Specialist will help manage select Corporate CQA activities in line with strategies and goals set by Quality and Clinical management.
Ensures clinical research activities conform to federal and international standards and BSC processes and expectations.
This role will help drive the implementation of Quality Management-approved solutions to ensure compliance through effective, efficient, and sustainable processes.
Key responsibilities include:
Work with Quality and Clinical Stewards and senior management to support maintenance of the Product Approval - Clinical Trial quality system subprocess including process improvements, maintenance of procedures to regulatory requirements, and addressing compliance risks.
Collaborate with Global Clinical Operations to ensure ongoing compliance of clinical research activities and operational efficiency through support of CAPAs, process improvement initiatives, and clinical systems.
Acts as a consultant relative to the interpretation of regulations and their impact on Clinical trial processes and implementation of new QS requirements.
Help identify key areas of regulatory risk and suggest potential resolutions as well as ways to improve compliance to regulations and BSC policies and procedures.
Partner with divisional/regional Clinical Quality teams to gather data for management reviews.
Support analysis of Clinical metrics to identify opportunities for improvement Support internal and external audits of BSC, as needed.
Review BSC policies and procedures to ensure compliance with external and internal requirements.
Contribute as SME to the development and maintenance of BSC policies and procedures, as needed.
Lead project activities, as needed, under the direction of Quality Management.
Develop project plans outlining work plans, timelines, roles and resources.
Communicate status, risks, and resolutions to management on key initiatives.
Create relationships across the business that enable sharing of knowledge, best practices, and solutions that can be leveraged across Clinical.
Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
5-10% potential domestic travel What we're looking for in you:
Minimum
Qualifications:
Bachelor's degree in Life Sciences, Engineering, or related field Minimum of 7 years of Clinical Quality Systems, Clinical Operations/Project Management, or Regulatory Affairs experience Medical device industry experience required Knowledge of international standards, regulations and guidelines governing human subject research (ISO 14155, CFRs, EU MDR, MDCG Guidance, etc.
) Requisition ID:
565883Among other requirements, Boston Scientific maintains specific drug testing requirements for safety-sensitive positions.
This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a requirement.
The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
Recommended Skills Business Efficiency Business Process Improvement Clinical Research Clinical Trials Clinical Works Human Subject Research Estimated Salary: $20 to $28 per hour based on qualifications.
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