Senior Manager, Clinical Quality Assurance - Americas
Core
Drive quality excellence and ensure compliance across clinical research activities and global trials to achieve first-pass regulatory approvals for new therapies.
Role type
Senior Manager, Clinical Quality Assurance
Builds
Quality systems, audit strategies, and regulatory readiness for clinical development pipelines.
Domain
Biopharmaceuticals / Clinical Research / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality assurance, compliance, regulatory affairs, clinical research, risk management, auditing, change management, documentation standards, data integrity, leadership, strategic planning, cross-functional collaboration, audit response management, inspection readiness, corrective action planning, mentorship
Preferred skills
Knowledge of local and global regulatory requirements, ability to influence without direct authority, analytical skills, negotiation, networking, travel adaptability
Technologies
None explicitly listed
Responsibilities
Maintain collaborative relationships with RDQA functions and clinical development leaders to advance quality systems; oversee quality and compliance in regulated environments; lead risk identification and mitigation strategies for clinical trials; establish quality measures and drive quality strategy; manage governance and identify trends to mitigate risks; ensure consistent understanding of quality requirements; support supplier visits, audits, and vendor qualifications; develop inspection strategies and provide inspection-readiness support; provide oversight for Health Authority inspections; conduct audits to assess compliance and approve corrective action plans; mentor AREA Managers and Associates.
Seniority
Senior, hands-on IC with leadership responsibilities