Executive Director, Internal Manufacturing

Role Summary

We are seeking a dynamic and experienced Executive Director to lead our internal GMP manufacturing operations for pharmaceutical drug products. This role is critical to ensuring the successful, high-quality production of our drug products in compliance with regulatory standards. The ideal candidate will bring deep expertise in GMP manufacturing, a passion for operational excellence, and a proven ability to build and lead high-performing teams.

Responsibilities

• Manufacturing Leadership: Oversee all aspects of internal GMP drug product manufacturing operations, ensuring consistent, compliant, and efficient production.
• Quality & Compliance: Maintain rigorous quality standards and ensure full compliance with FDA and global regulatory requirements. Partner closely with Quality Assurance and Regulatory Affairs teams to ensure alignment and coordination of CMC activities and improvements.
• Operational Excellence: Drive continuous improvement initiatives across manufacturing processes, equipment utilization, and operational workflows to enhance productivity and reduce cost.
• Team Development: Recruit, mentor, and develop a high-performing manufacturing operations team that can meet production demands. Foster a team culture representative of Liquidia‚Äôs core values.
• Strategic Planning: Develop and execute long-term manufacturing strategies aligned with corporate goals, including capacity planning, technology upgrades, and risk mitigation.
• Cross-Functional Collaboration: Work closely with Supply Chain, External Manufacturing, Quality, R&D, and other departments to ensure seamless coordination and support for product launches and lifecycle management for current and future products.
• Budget & Resource Management: Manage departmental budgets, capital expenditures, and resource allocation to meet production targets and strategic objectives.

Qualifications

• Required: Bachelor‚Äôs degree in Engineering, Life Sciences, or related field; advanced degree (MS, MBA, PhD) preferred.
• Required: Minimum of 20 years of experience in pharmaceutical manufacturing, with at least 5 years in a senior leadership role overseeing commercial manufacturing and complex drug product formulation.
• Required: Deep understanding of GMP regulations and pharmaceutical production processes.
• Required: Proven track record of leading successful manufacturing operations and teams for different modalities.
• Required: Strong strategic thinking, problem-solving, and decision-making skills.
• Required: Excellent communication and leadership abilities.
• Preferred: Lean Six Sigma or other operational excellence certifications.