Provide direct line management and performance oversight for the Clinical Quality team, including resource planning, project timeline adherence, and compliance with applicable regulations and internal procedures.
Support and empower the Clinical Quality team in driving the strategic application of regulatory standards, industry guidelines, and internal processes across all phases of clinical study conduct (planning, execution, and closeout).
Collaborate with study teams to proactively influence clinical operations and ensure compliance; provide guidance to remediate non-compliance and restore alignment with regulatory and organizational expectations.
Maintain oversight of Corrective and Preventive Action (CAPA) processes and audit responses related to clinical research.
Oversee Clinical Quality Management System and drive training/compliance.
Establish and promote mechanisms for sharing best practices and lessons learned across the organization.
Identify and escalate significant compliance risks to Medical Affairs leadership, ensuring timely and effective resolution through appropriate remediation strategies.
Manage performance development for direct reports, including ongoing feedback, formal reviews, and succession planning.
Oversee recruitment, onboarding, and ongoing training of Clinical Quality staff, ensuring alignment with evolving organizational needs.
Review and approve team-related expenses, ensuring compliance with corporate travel and expense policies.

Bachelor’s degree
7 years of experience in a quality role within clinical trials (e.g., clinical quality, clinical compliance, or clinical auditing)
7 years of experience in a quality role within diagnostic clinical trials (preferred)
2 years of experience as a direct people leader (preferred)
2 years of experience in clinical monitoring or study management (preferred)
Mastery of MedTech regulations and standards (e.g., 21 CFR 812, 50, 54, 56, ISO 14155, ISO 20916, ISO 13485, ISO 14971, EU MDR/IVDR, China FDA, JGCP, ICH E6)

Senior Manager, Clinical Quality

Key skills