Associate Director, Quality Assurance, Transformational Lead
Core
Provide strategic quality leadership to ensure compliance with regulatory requirements and deliver life-changing therapies.
Role type
Senior IC quality assurance director (pharmaceutical manufacturing)
Builds
Medicines and therapies for patients globally
Domain
Life sciences / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations, FDA regulations (CFR Parts 11, 210, 211, 820), quality systems management, investigations, change controls, CAPA programs, risk-based quality strategies, team leadership
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead and oversee the site's Quality Assurance Management System; Serve as primary QA contact for site quality systems; Oversee investigations, change controls, and CAPAs; Lead, coach, and develop QA team members; Support client and regulatory audits; Partner with stakeholders to drive quality initiatives; Lead risk-based quality strategies and continuous improvement projects
Seniority
Senior, hands-on IC with strategic leadership
