Site Quality Head, Quality Director
Core
Lead Quality Assurance initiatives for an Oral Solid Dose CDMO facility, ensuring regulatory compliance and product quality for tablets, capsules, granules, and soft gel formulations.
Role type
Senior IC Site Quality Head / Quality Director
Builds
High quality pharmaceutical products (tablets, capsules, granules, soft gels) for CDMO clients
Domain
Life Sciences / Pharmaceutical Manufacturing (Oral Solid Dose)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical Quality System (PQS) execution, regulatory compliance (FDA 21 CFR, EU GMP, ICH), risk management (ICH Q9/Q10), data integrity (ALCOA+), validation lifecycle management, root cause analysis, team leadership, batch disposition authority
Preferred skills
Multilingual abilities, continuous improvement initiatives, quality management software proficiency
Technologies
Quality management software systems
Responsibilities
Establish and implement site quality strategy, represent Quality on Site Leadership Team, ensure compliance with global regulatory standards, maintain inspection readiness, provide quality oversight for OSD manufacturing, lead the Pharmaceutical Quality System, hold final authority for batch disposition, serve as senior quality interface for clients, lead and develop the quality organization, oversee granulation/compression/coating processes, manage blend and content uniformity controls, supervise dissolution testing and stability programs, direct cleaning and process validation, exercise authority to halt manufacturing, support client audits, build high-performing teams, monitor KPIs
Seniority
Senior, hands-on IC with strategic leadership
