The Sr. Manager Clinical Quality serves as a key leader within the Medical Affairs organization responsible for ensuring regulatory compliance and subject safety across clinical research activities
Job Summary
The Sr. Manager Clinical Quality serves as a key leader within the Medical Affairs organization responsible for ensuring regulatory compliance and subject safety across clinical research activities.
This role requires managing a team dedicated to overseeing Corrective and Preventive Action processes while maintaining alignment with global regulatory standards like ISO 14155 and EU MDR/IVDR.
Candidates must demonstrate strong leadership capabilities with a natural aptitude for mentoring talent while thriving in a culture that prioritizes on-site collaboration for innovation.
Matching Summary
The Sr. Manager Clinical Quality serves as a key leader within the Medical Affairs organization responsible for ensuring regulatory compliance and subject safety across clinical research activities.
Salary
Base: $143,900.00 - $237,600.00 USD Annual; Bonus/Equity: Not specified; Benefits: Comprehensive Total Rewards program mentioned
Skills & Requirements
Must-have
7 years experience in clinical quality role
Direct people leadership experience
Knowledge of ISO 14155 and ISO 13485 standards
Experience with CAPA processes and audit responses
Strong understanding of GCP and FDA regulations
Nice-to-have
Experience in diagnostic clinical trials
Background in clinical monitoring or study management
Proven track record of driving process improvements
Ability to mentor and develop talent effectively
Experience navigating uncertainty and complex projects
Key Requirements
Bachelor's degree required
Minimum 7 years in clinical quality/compliance
2 years direct people leadership experience
Mastery of MedTech regulations including 21 CFR 812
Experience in diagnostic clinical trials preferred