Director, Third Party Manufacturing

AbbVie • North Chicago, IL

6h

About The Position

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.

Requirements

• 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.

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.

Benefits

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 401(k)
• long-term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Director