Senior Manager, Clinical Quality Assurance
Core
Drive quality excellence and ensure compliance in clinical research activities across designated countries to achieve first-pass approvals for new therapies.
Role type
Senior Manager, Clinical Quality Assurance
Builds
Robust audit and inspection responses, quality strategies, and regulatory preparedness for clinical trials.
Domain
Biopharmaceutical / Medical Device industry, Clinical Research, Regulatory Affairs
Required skills
Quality systems knowledge, auditing standards, risk management, regulatory compliance, leadership, strategic planning, data analysis, cross-functional collaboration, audit execution, inspection readiness, corrective action planning, mentorship
Preferred skills
Additional languages, travel adaptability
Technologies
None stated
Responsibilities
Maintain collaborative relationships with RDQA functions and clinical development leaders; oversee quality and compliance in regulated environments; lead risk identification and mitigation strategies; establish quality measures and drive quality strategy; manage governance for the One AbbVie Quality System; ensure consistent understanding of quality requirements; maintain awareness of regulations and develop quality standards; support supplier visits, audits, and vendor qualifications; develop inspection strategies and provide inspection-readiness support; provide oversight for Health Authority inspections; determine need for country/process assessments; conduct audits to assess compliance; support development of audit responses through coaching; mentor AREA Managers/Associates
Seniority
Senior, hands-on IC with leadership responsibilities
