Executive Director, Quality Site Head Stein
Core
Leading all quality-related activities, strategy, and governance for a Drug Product manufacturing site to ensure regulatory compliance, patient safety, and operational excellence during site expansion.
Role type
Executive Director, Quality Site Head
Builds
Drug Product manufacturing capabilities and site operations for a Contract Development and Manufacturing Organization (CDMO)
Domain
Life Sciences / Pharmaceutical Manufacturing / Quality Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality oversight for Drug Product manufacturing)
Required skills
Pharmaceutical Quality Leadership, GxP Compliance, Regulatory Inspection Management, Organizational Development, Risk Management, Continuous Improvement Methodologies, Stakeholder Engagement, Strategic Planning
Preferred skills
Biologics expertise, Sterile Manufacturing knowledge, Site expansion experience, Advanced quality qualifications
Technologies
Six Sigma, Lean, FMEA, SPC, Digital quality tools
Responsibilities
Define and execute site quality strategy, lead Quality Assurance/Control/Compliance/Validation functions, ensure regulatory compliance with FDA/EMA/Swissmedic, lead regulatory inspections and audits, develop quality organization for site growth, drive continuous improvement initiatives, manage deviations and CAPAs, represent site in customer and regulatory interactions
Seniority
Executive Director, Site Leadership
