Director, Third Party Manufacturing

AbbVie

Ludwigshafen, Germany

The Director, Third Party Manufacturing is responsible for leading and overseeing the end-to-end management of third-party manufacturing operations for assigned products and partners. This role ensures compliant, efficient, and high-quality manufacturing execution through strong cross-functional collaboration, technical oversight, and proactive issue resolution. The position also leads team development and drives continuous improvement across external manufacturing processes and interfaces.

Your tasks and responsibilities:

Lead the management of third-party manufacturing activities for assigned products, sites, and external partners to ensure supply continuity and operational excellence. Accountable for all GMP third-party drug product manufacturing activities within R&D;
Oversee the initiation, review, and approval of key external manufacturing documentation and agreements, including CDAs, RFPs, MSAs, and technical quality agreements;
Coordinate with TPMs, AbbVie Operations, QA, R&D, Legal, Procurement, Business Operations, Analytical, VLOG, and other functions to ensure alignment 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, in-licensed projects, and opt-in programs;
Ensure manufacturing processes and documentation meet AbbVie and external 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 strong manufacturing performance;
Drive cross-functional process improvements and standardization initiatives 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.

Qualifications:

Bachelor’s degree in a scientific, engineering, or related discipline required; advanced degree preferred;
Extensive experience in pharmaceutical or biopharmaceutical manufacturing, third-party manufacturing, quality, technical operations, or supply chain support;
Demonstrated experience managing external manufacturing partners, CMOs/TPMs, or contract manufacturing relationships;
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 with experience managing people or leading through influence;
Excellent problem-solving, decision-making, and escalation management skills in a highly regulated environment;
Ability to manage multiple priorities, complex projects, and detailed operational activities with a high degree of accountability;
Strong communication, collaboration, and relationship-building skills with internal and external stakeholders.