Hanane AL KHALILI
@hananealkhalili
Senior Quality and Compliance leader specializing in supplier oversight, PV, and audit programs.
United StatesWhat I'm looking for
I am a quality and compliance professional with deep expertise in supplier oversight, pharmacovigilance (PV), clinical quality auditing, and risk-based quality governance. I lead strategic and tactical audit programs and manage critical third-party suppliers to ensure regulatory compliance and operational excellence.
At global pharmaceutical companies, I have overseen end-to-end supplier audit programs (GCP, GCLP, GVP), supported inspection readiness, and maintained controlled documents and QA inputs for safety and clinical agreements. I analyze audit trends to identify systemic issues and drive remediation.
I built and led a Consultant Auditor Framework, mentored junior staff, and directed vigilance and device vigilance operations, including SOP development, KPI monitoring, CAPA oversight, and business continuity planning. I have implemented remote, risk-based supplier auditing and strengthened PV reporting compliance.
I bring a Master of Science in Regulatory Affairs and Certified Quality Auditor (CQA) certification, combining regulatory knowledge (FDA/EMA/MHRA, ICH-GCP/GVP, 21 CFR Part 11) with hands-on experience using tools like Veeva Vault and TrackWise to improve supplier governance and quality systems.
Experience
Work history, roles, and key accomplishments
TPOversee global supplier quality and compliance for Clinical, Medical, and Pharmacovigilance partners, leading a risk-based audit program and improving supplier remediation and inspection readiness across business partners.
NPLed global Quality and PV supplier audits from planning through CAPA, implemented remote risk-based supplier auditing, and strengthened supplier governance, KPIs, and PV reporting compliance.
NPSupervised vigilance operations and case handling, led SOP development and change controls, and directed post-market surveillance and Safety Data Exchange Agreements to ensure regulatory compliance.
NPLed local implementation and oversight of vigilance and case-handling systems, maintained safety data exchange agreements, and improved local SOPs and training to align with global regulatory expectations.
Quality Auditor / Sr. Quality Specialist
Bioventus LLC
Jan 2012 - Dec 2015 (3 years 11 months)
Developed complaint handling and PV processes during a corporate transition, led internal and supplier audits, managed adverse event reporting, and implemented CAPAs to resolve non-conformities.
Education
Degrees, certifications, and relevant coursework
AQAmerican Society for Quality
Certified Quality Auditor (CQA), Quality Auditing
Certified Quality Auditor (CQA) credential awarded in May 2019 demonstrating professional competency in quality auditing.
NUNortheastern University
Master of Science, Regulatory Affairs
Master of Science in Regulatory Affairs completed in 2012 with focus on regulatory requirements and compliance.
RCRhode Island College
Bachelor of Science, Biology
Bachelor of Science in Biology with a minor in Chemistry completed in 2009, focused on biological sciences and laboratory fundamentals.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
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