Director, Compliance
Core
Leads QA Compliance team activities, risk management, and regulatory inspections for aseptic/sterile production environments.
Role type
Senior IC Director of Compliance (Pharma/Contract Manufacturing)
Builds
QMS processes, audit programs, and regulatory readiness for contract manufacturing sites
Domain
Biopharma / Contract Manufacturing / Quality Systems
Required skills
Global regulatory guidance knowledge (CFR 210/211, 820, cGXP, ICH Q8/Q9/Q10, EU/Eudralex), QMS data management software proficiency, risk assessment, audit investigation, CAPA management, stakeholder collaboration
Preferred skills
Advanced degree in life sciences/chemistry/engineering, Contract Manufacturing experience, Industry experience outside of Quality
Technologies
eQMS, process mapping tools, risk assessment software, data analysis tools
Responsibilities
Manage internal/external audits and regulatory inspections, oversee risk management program integration, lead complex audit/deviation/CAPA investigations, manage quality event trends and metrics, drive process improvement initiatives, prepare site for regulatory inspections
Seniority
Director, management level
