Associate Director / Director, Quality Assurance
Core
Senior QA leader owning the Quality Management System for an outsourced manufacturing model, including document control, GMP training, and supplier/vendor audit programs.
Role type
Senior individual contributor (Associate Director/Director)
Builds
Inspection-ready Quality Management System (QMS) for pharmaceutical/biotech products
Domain
Pharmaceutical/Biotech Quality Assurance
Required skills
GMP compliance, document control, GMP training program management, supplier qualification and audit leadership, regulatory inspection readiness, cross-functional influence, data integrity (ALCOA+), 21 CFR 210/211, Part 11, ICH Q7–Q10, EU GMP
Preferred skills
Drug-device combination product experience, Veeva Vault QMS administration, ASQ CQA or lead auditor certification, building quality systems at growing companies
Technologies
Veeva Vault QualityDocs
Responsibilities
Set quality strategy and objectives; lead cross-functional quality initiatives; own QA metrics and KPIs; lead FDA/regulatory inspections; manage document control lifecycle; deliver GMP training; run supplier and vendor audits; negotiate quality agreements
Seniority
Senior, hands-on IC
