Head of External Sterile Operations

Overview

This leadership role, based in Ireland, focuses on directing the strategy, governance, and execution of an external sterile manufacturing network within a strictly regulated healthcare environment. The position involves overseeing crucial supplier partnerships to guarantee dependable supply, operational excellence, and long-term value across external manufacturing operations. It requires a blend of strategic leadership, collaboration across functions, and proactive management of relationships with key external partners.

Key Responsibilities

• Lead and mentor a team of External Operations Managers responsible for third-party manufacturing partnerships.
• Develop and implement strategy, governance frameworks, and performance criteria for external sterile manufacturing collaborators.
• Maintain senior-level supplier relationship management covering supply, quality, service, cost, compliance, and operational effectiveness.
• Conduct executive business reviews, governance sessions, and strategic dialogues with external manufacturing collaborators.
• Drive high-stakes commercial, contractual, and capacity negotiations with external suppliers.
• Collaborate closely with Supply Chain and organizational leaders to synchronize capacity plans, supply strategies, and network priorities.
• Handle critical escalations related to supply interruptions, operational issues, quality challenges, and performance risks.
• Foster robust cross-functional cooperation involving Quality, Technical Services, Procurement, Legal, Manufacturing, and Supply Chain teams.
• Define standards, processes, and exemplary practices for governance and supplier management in external operations.
• Support initiatives such as product transfers, launches, lifecycle adjustments, and network optimization with external manufacturers.

Candidate Profile

• Possess over 15 years of experience in sterile operations, pharmaceutical manufacturing, biotechnology, or comparable regulated sectors.
• Demonstrated management of complex third-party manufacturing and Contract Development and Manufacturing Organization (CDMO) partnerships.
• Robust experience in external manufacturing, supplier relationship management, supply chain, technical operations, procurement, or quality assurance functions.
• Proven leadership in guiding cross-functional teams within matrixed organizations.
• Expertise in negotiating commercial contracts, capacity agreements, and strategic partnerships.
• Strong analytical and problem-solving capabilities for addressing supply disruptions and operational risks.
• Development and implementation of supplier governance models, performance metrics, and risk management approaches.
• Experience managing senior professionals and managers.
• In-depth understanding of sterile manufacturing networks and external manufacturing supply chains is highly advantageous.
• Familiarity with product transfer projects, launches, lifecycle management, or manufacturing network changes is preferred.
• Excellent communication, influencing aptitude, and presentation skills at the executive level.

Benefits

• Attractive salary reflecting experience and current market standards.
• Comprehensive benefits supporting health, wellness, and financial security.
• An inclusive, collaborative culture that values innovation and impactful work.
• Opportunities for professional growth and advancement in leadership roles.
• Flexible work arrangements, including options for remote work.
• The chance to contribute meaningfully to global healthcare and improve access to essential medicines.

Additional Information

This role partners closely with Supply Chain, Quality, Technical Services, Procurement, and business leaders to shape and enhance external manufacturing operations. The final hiring decisions rest with the partner company managing the application process and subsequent procedures. The recruitment process may utilize AI-powered tools for application assessment, though human judgment remains essential.