Director, Third Party Manufacturing

Job Description

Mandated role: 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.

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, Abb Vie 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 Abb Vie 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.

Benefits

• Diverse work environment with real impact.
• Open corporate culture.
• Attractive salary.
• Intensive onboarding process with a mentor.
• Flexible work models for a healthy work‑life balance.
• Corporate health management with comprehensive health and exercise programs.
• Company social benefits.
• Wide range of career opportunities in an international organization.
• Top‑tier, attractive development opportunities.
• Strong international network.
• Equal Opportunity Employer

Abb Vie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.

We are an Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only – to learn more, visit https://www. abbvie. com/join-us/equal-employment-opportunity-employer. html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www. abbvie. com/join-us/reasonable-accommodations. html

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