Director, Third Party Manufacturing (all genders) (full-time, permanent)
Hybrid · Ludwigshafen am Rhein, Rheinland-Pfalz, Germany
Job Summary
Lead end-to-end management of third-party manufacturing activities for assigned products and external partners to ensure supply continuity and operational excellence. Oversee initiation, review, and approval of external manufacturing documentation and agreements (CDAs, RFPs, MSAs, technical quality agreements). Coordinate with TPMs, QA, R&D, Legal, Procurement, and other functions to align on manufacturing instructions, batch records, sample coordination, and shipment execution. Serve as a key point of contact for third-party manufacturing issues, escalations, deviations, and investigations, ensuring timely resolution and strong quality outcomes. Support tech transfer and post-transfer manufacturing readiness for clinical and commercial supply, including new collaborations and in-licensed projects. Ensure manufacturing processes and documentation meet regulatory expectations, including proper handling of batch records, release processes, and quality documentation. Lead and participate in audits, site visits, and technical assessments to evaluate partner capabilities and maintain manufacturing performance. Drive cross-functional process improvements and standardization across third-party manufacturing and related supply chain processes. Monitor external partner performance and manage relationships to support successful execution of manufacturing campaigns and continuous improvement. Develop, coach, and hold team members accountable for performance, capability growth, and effective execution of routine and technical responsibilities.
Required Qualifications
- Bachelor’s degree in a scientific, engineering, or related discipline
- Advanced degree preferred
- Experience in pharmaceutical or biopharmaceutical manufacturing
- Experience managing external manufacturing partners (CMOs/TPMs)
- Strong knowledge of GMP requirements, quality systems, batch record documentation, and technical quality agreements
- Experience supporting tech transfer, manufacturing readiness, and clinical or commercial supply operations
- Proven ability to work effectively across QA, R&D, Operations, Legal, Analytical, Procurement, and supply chain functions
- Strong leadership, coaching, and team development skills
- Excellent problem-solving, decision-making, and escalation management skills in a highly regulated environment
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