Head of External Sterile Operations

Overview

This leadership role based in Germany oversees the strategy, governance, and performance management of an external sterile manufacturing network within a tightly regulated healthcare setting. The position encompasses managing vital supplier partnerships to secure reliable supply, operational excellence, and long-term value across external manufacturing.

The Head of External Sterile Operations will lead teams, foster cross-functional collaboration, and maintain hands-on relationships with critical external partners. This role requires driving performance improvements, handling complex negotiations, and ensuring business continuity globally. Working closely with departments like Supply Chain, Quality, Technical Services, Procurement, and business leaders, the role significantly influences external operations management and optimization. The ultimate goal is to ensure continued patient access to high-quality medicines.

Primary Responsibilities

• Lead and mentor a team of External Operations Managers responsible for key third-party manufacturing partnerships.
• Develop and implement strategies, governance frameworks, and performance benchmarks for external sterile manufacturing partners.
• Manage high-level supplier relationships focusing on supply, quality, service, cost, compliance, and operational excellence.
• Conduct executive business reviews, governance meetings, and strategic engagements with manufacturing partners.
• Lead major commercial, contractual, and capacity negotiations with suppliers.
• Collaborate with Supply Chain and business leaders to align capacity planning, supply approaches, and network priorities.
• Address significant escalations relating to supply disruptions, operational issues, quality concerns, and performance risks.
• Promote strong coordination across Quality, Technical Services, Procurement, Legal, Manufacturing, and Supply Chain teams.
• Establish standards, processes, and best practices for governance and management of external operations.
• Support activities related to product transfers, launches, lifecycle changes, and network optimization involving external manufacturers.

Candidate Requirements

• Minimum of 15 years experience in sterile operations, pharmaceutical manufacturing, biotech operations, or comparable regulated industries.
• Proven expertise in managing complex third-party manufacturing or CDMO partnerships.
• Strong background in external manufacturing, supplier relationship management, supply chain, technical operations, procurement, or quality functions.
• Experience leading cross-functional teams within matrix organizations.
• Track record of successful negotiations of commercial agreements, contracts, capacity commitments, and strategic partnerships.
• Excellent problem-solving skills managing supply disruptions, escalations, and operational risks.
• Skilled at developing supplier governance frameworks, performance scorecards, and risk mitigation strategies.
• Prior experience managing teams, including managers or senior operational professionals.
• Familiarity with sterile manufacturing networks, sterile supply chains, and external production environments preferred.
• Experience in product transfers, launches, lifecycle management, or network changes is advantageous.
• Strong communication skills with ability to influence and present at executive levels.

Benefits

• Competitive salary aligned with experience and market benchmarks.
• Comprehensive benefits to support health, wellbeing, and financial security.
• Inclusive, innovative, and collaborative workplace culture.
• Opportunities for professional growth, development, and leadership advancement.
• Flexible work options including remote arrangements.
• Chance to contribute to global healthcare operations and enhance access to critical medicines.

Additional Information

This position is listed on behalf of a partner organization that manages applications and subsequent hiring steps directly. Candidates will undergo an AI-powered matching process for objective review, but final recruitment decisions are made by the partner company. Data privacy is ensured per GDPR regulations, with transparency about AI use in screening. The role offers a chance to impact healthcare delivery significantly by ensuring continuous availability of quality medicines worldwide.