Associate Director, QA
Core
Leads and develops a team of Clinical Auditors in the Americas to build-in quality to AbbVie processes and execute risk-based clinical audit programs.
Role type
Senior IC clinical audit leader (Americas)
Builds
Clinical audit programs and quality systems for clinical development
Domain
Pharmaceutical industry, clinical development, quality assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical audit leadership, risk-based audit program execution, GxP compliance, clinical regulatory knowledge, cross-functional team management, strategic planning, process improvement, complex issue management, stakeholder alignment
Preferred skills
Experience with regulatory authorities, inspection support, global/regional regulations (ICH, ISO)
Technologies
GxP systems, clinical development tools
Responsibilities
Lead and develop a team of Clinical Auditors based in the Americas; Contribute to the development of the global Clinical Audit strategy at an Americas level; Execute complex audits and resolve non-compliance issues; Drive development and continuous improvement of quality and clinical systems; Analyze and evaluate processes supporting clinical development; Provide expert advice on clinical regulations and guidance; Support GCP inspections onsite or remotely
Seniority
Senior, hands-on IC with strategic leadership