The Enterprise Implementation Lead is accountable for the enterprise-wide technical implementation and validation of the Horizon 2 program, a patented, yield enhancing manufacturing technology
Job Summary
The Enterprise Implementation Lead is accountable for the enterprise-wide technical implementation and validation of the Horizon 2 program, a patented, yield enhancing manufacturing technology.
This role involves translating development outputs into scalable, compliant manufacturing solutions and ensuring robust process knowledge, control strategies, and validation evidence for global regulatory filings.
Partner with Manufacturing, Engineering & Maintenance, Quality, and Regulatory Affairs to ensure alignment between technical execution, operational readiness, and regulatory commitments.
Matching Summary
The Enterprise Implementation Lead is accountable for the enterprise-wide technical implementation and validation of the Horizon 2 program, a patented, yield enhancing manufacturing technology.
Skills & Requirements
Must-have
Enterprise-wide technical implementation
Process implementation strategies
Validation strategy and execution
Regulatory submission content development
Technical risk management
Cross-functional integration and governance
Nice-to-have
Enterprise mindset and CSL values
Continuous improvement across deployments
Data-driven decision making
Lean, senior implementation team leadership
Key Requirements
Bachelor's degree in scientific or engineering discipline
15+ years of professional experience in biopharma/biotech/life sciences
Experience in drug development, manufacturing, technical transfer, Validation, CMC regulatory processes
Demonstrated leadership of enterprise-scale programs
Proven ability to lead in complex, matrixed, global organizations