Quality Director
Core
Lead the full site Quality organization and act as the registered Qualified Person (QP) for an Oral Solid Dose manufacturing site, ensuring regulatory compliance and inspection readiness.
Role type
Senior IC Quality Director (Qualified Person)
Builds
Production of oral solid dose drug products for pharmaceutical and biotech clients
Domain
Pharmaceutical manufacturing (CDMO), Oral Solid Dose (OSD)
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Qualified Person (QP) registration, EU/FDA regulatory compliance, regulatory inspection leadership, CAPA management, change control, deviation management, validation oversight, NDA submission support, organizational leadership (8-10 direct reports), risk-based decision-making
Preferred skills
CDMO client-facing quality governance, Lean/Six Sigma, operational excellence methodologies (PPI, DMAIC, 8D)
Technologies
EU GMP, FDA CFR, CAPA systems, FMEA, SPC
Responsibilities
Lead the full site Quality organization (QA, QC, Compliance, Validation, Quality Systems), Act as the registered Qualified Person (QP) for the site, Ensure compliance with French, EU, FDA, and global regulatory standards, Lead regulatory inspections and manage interactions with ANSM, EMA, FDA, and other authorities, Drive a proactive quality culture with strong risk-based decision-making, Oversee CAPA, deviations, change control, complaints, validation, and inspection readiness, Support NDA submissions and regulatory filing activities, Partner cross-functionally with Operations, Supply Chain, Technical, and Global Quality, Develop and lead a large, multi-layered Quality organization, Champion continuous improvement initiatives (PPI, Lean, DMAIC, 8D)
Seniority
Senior, hands-on IC
