Director, Third Party Manufacturing

About the 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.
• Oversee the initiation, review, and approval of key external manufacturing documentation and agreements, including CDAs, RFPs, MSAs, and technical quality agreements.
• Carefully 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.
• Maintain and manage relationships with external partners 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.

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.
• Able 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.

Qualifications

• Minimum of 10 years of relevant experience in pharmaceutical or biopharmaceutical manufacturing, third-party manufacturing, quality, technical operations, or supply chain support.
• Proven track record of successfully managing external manufacturing partners, CMOs/TPMs, or contract manufacturing relationships.
• Advanced degree in a relevant field (Pharmaceutical Sciences, Biotechnology, Chemical Engineering, etc.) preferred.

Skills

• Strong knowledge of Good Manufacturing Practices (GMP).
• Experience with regulatory compliance and quality assurance.
• Ability to lead and mentor a team.
• Effective communication and interpersonal skills.
• Proficiency in Microsoft Office Suite.

Benefits

AbbVie offers a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and a 401(k) plan to eligible employees. Additionally, this role is eligible to participate in AbbVie's long-term incentive programs.

Pay

The compensation range for this role is $XX - $YY. Individual compensation within this range will depend on many factors including geographic location.

Schedule

This role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.