Associate Director, QA
Core
Leads the Americas Clinical Quality Audit team to assure quality and compliance of clinical trials and studies for AbbVie in a regulated environment.
Role type
Senior leadership IC clinical quality audit manager
Builds
Clinical audit programs and quality systems for global clinical development
Domain
Pharmaceutical industry, clinical trials, regulatory affairs, quality assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic planning, team leadership, risk management, regulatory compliance, process improvement, cross-functional collaboration, stakeholder management, complex issue resolution, analytical thinking, communication
Preferred skills
Experience with GCP inspections, knowledge of ICH and ISO standards, ability to manage international travel
Technologies
GxP systems, clinical trial management systems
Responsibilities
Lead and develop a team of Clinical Auditors across the Americas, contribute to global Clinical Audit strategy, provide leadership on risk-based clinical audit programs, drive continuous improvement of quality systems, analyze processes to assure compliance, provide expert advice on clinical regulations, support GCP inspections
Seniority
Director level, strategic leadership with hands-on team management