Director, Facilities & Equipment Quality Strategy, and Technical Oversight Support
Core
Provide global Quality leadership for GMP facilities, utilities, and equipment across the company network, ensuring infrastructure compliance, reliability, and fit for intended use throughout their lifecycle.
Role type
Director, Facilities & Equipment Quality Strategy and Technical Oversight
Builds
GMP-compliant manufacturing infrastructure, utilities, and equipment assets for cell and gene therapy treatments
Domain
Biopharmaceutical manufacturing (cell and gene therapy), Facilities Engineering, Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure
Required skills
GMP compliance, risk-based decision making, lifecycle management, regulatory guidance application (FDA/ICH/ISPE), harmonization, continuous improvement, control strategy development, investigation leadership, regulatory submission oversight
Preferred skills
Commissioning/qualification/validation of facilities, reliability engineering, global cross-functional team leadership, cell and gene therapy manufacturing experience, CQE or CQA certification
Technologies
GMP standards, FDA/ICH/ISPE guidance, engineering standards, Quality by Design principles
Responsibilities
Define and maintain enterprise policies and standards for facilities and equipment quality; Provide independent Quality review and approval for facilities, utilities, and equipment lifecycle; Lead network-wide harmonization and continuous improvement; Oversee significant investigations and corrective actions; Represent Quality in governance forums and regulatory interactions; Guide risk-based decisions for new process design and facility start-up
Seniority
Director, strategic leadership with hands-on technical oversight
