We are seeking an experienced Site Director to lead manufacturing and supply chain operations at a GMP-regulated facility. This senior leadership role is responsible for ensuring the safe, compliant, and reliable delivery of clinical and commercial products while driving operational excellence, workforce development, and continuous improvement.
Key Responsibilities
* Lead manufacturing and supply chain operations to ensure on-time product availability.
* Drive a strong culture of safety, quality, compliance, and operational excellence.
* Develop site capabilities, capacity, and workforce plans to support business growth and supply requirements.
* Collaborate cross-functionally to deliver operational strategy and achieve business objectives.
* Oversee budgets, resource planning, and continuous improvement initiatives.
* Ensure compliance with GMP, data integrity, documentation standards, and regulatory requirements.
* Support successful regulatory inspections and the timely resolution of quality-related commitments.
Key Requirements
* Significant leadership experience in GMP manufacturing and regulated operations.
* Proven experience leading new product introductions (NPI), technology transfers, scale-up activities, and the successful transition of products from development into routine GMP clinical and commercial manufacturing.
* Strong knowledge of quality systems, regulatory compliance, and EHS requirements.
* Proven ability to lead, develop, and motivate high-performing teams in a growing and evolving environment.
* Experience managing operational budgets, forecasting, and strategic planning.
* Demonstrated success in driving continuous improvement and operational performance.