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.
Director, Clinical Quality Assurance
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.
General Summary:
The Director of Clinical Quality Assurance (QA) will focus on the implementation of the Global clinical quality assurance audit programs to access GCP and GLP compliance throughout Boston Scientific. The Director will provide leadership and functional oversight to the Clinical Quality Assurance and Pre-Clinical Quality Assurance Groups. These groups will ensure the processes and policies are implemented and maintained throughout the Clinical organization in accordance with Good Clinical Practices (GCP), Good Laboratory Practices (GLP) ; Boston Scientifics’ Clinical Project Process (CPP) and all appropriate regulations.
Duties and Responsibilities:
Manage compliance audit programs for both GCP and GLP
Lead GCP and GLP compliance improvement activities
Works closely with the Clinical Quality Management team to implement processes and systems that drive compliance to meet global regulatory requirements and collaborate with Clinical Sciences management to ensure compliance of all quality processes and procedures.
Creates and maintains a strong relationship with the Clinical Leadership team and participates in all appropriate meetings and venues. Work with the Clinical Quality Management and BSC Quality Management team to ensure continuity between Clinical and Quality activities.
Ensure visibility to and management of any noted deviations or deficiencies with GCP or GLP audits, through trend and root cause analysis by collaborating with clinical quality systems team to analyze audit results and report findings to senior management.
Provide guidance and direction on Quality Assurance matters within the Clinical Sciences group.
Promotes the Quality Policy and Good Clinical and Laboratory Practices at all levels within the organization.
Foster consistent Quality Assurance processes between the various divisions of clinical and pre-clinical sciences.
Ensure an appropriate strategy and execution for internal clinical audits through defined processes and practices
Ensures that all the appropriate SOPs are in place and that the appropriate level of training and comprehension has occurred.
Ensures that all quality based deliverables are complying with regulatory and quality policies and procedures.
Manages the budget to ensure adequate funding of all GCP and GLP programs and support due diligence and acquisition audits.
Ensures all staff is appropriately resourced, supported and has the tools and direction to properly execute their function.
Allocates/re-allocates internal and external resources, as needed
Encourages problem-solving processes leading to solutions for leverage across divisions, regions.
Keeps current on changes to all regulatory requirements and with other members of the Clincial QA management team , facilitates implementation into the Boston Scientific systems.
Coaches, develops and mentors Quality employees. Participate in succession planning, and the development and implementation of retention strategies of staff.
Ensure implementation of functional excellence initiatives.
Minimum Education & Experience:
Candidate possesses a B.S. Degree with 8+ Years Experience; clinically relevant experience needed; 5 years of management experience in an audit or clinical quality assurance department. An advanced engineering degree or MBA is highly desirable.
Expert knowledge of good clinical and laboratory practice, (GCP & GLP, both US and international)
Audit program implementation experience including interpreting regulations, guidelines, and identification of compliance issues.
Working Conditions:
General office environment, with potential (domestic and international) travel to BSC facilities for audits and other meetings, travel to support investigator site audits as necessary.
Competency Expectations:
Demonstrated success in creating a strategies to lead a team to success
Must be thoroughly familiar with the FDA and CE Marking and the Boston Scientific quality requirements associated with developing products in a regulated industry
Considerable personal experience presenting, interacting, and building effective relationships with regulatory agencies and senior management.
Excellent communication and presentation skills (articulate and persuasive)
Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with medical professionals.
Teaches/coaches others in technical and leadership areas.
Good administrative skills including budget management and departmental operations
Strong leadership and mentoring capabilities to support compliance teams.
