Associate Director, External Manufacturing - Biologics

Role Summary

The Associate Director, Third Party Manufacturing (TPM) Manager leads supplier relationships and oversees organization, supervision, strategic initiatives, and technical support to manage supply of designated biologics products. The role ensures high-quality manufacturing in compliance with regulations, and on-time release and delivery per forecasts, schedules, and cost plans. It also manages projects to ensure cost-effectiveness, marketability, and manufacturability throughout the product life cycle, coordinating cross-functional teams and acting as the primary AbbVie representative with the supplier.

Responsibilities

• Participate in the negotiation of the Manufacturing Service Agreement and amendments, ensuring compliance with terms.
• Ensure effective planning and material procurement strategies are in place to supply the TPM with required materials.
• Communicate product forecasts to the TPM and agree on manufacturing and delivery schedules; coordinate with Supply Chain and Planning to meet demand.
• Participate in development of Financial Operating Plan, Updates, LRP, and standard processes, ensuring financial goals are met.
• Coordinate Steering Committee and monitor Virtual Operation Teams to evaluate performance and escalate issues as needed.
• Review status reports and prepare updates for Senior leadership.
• Collaborate with technical and quality teams to review process performance, quality trends, and agree on improvement plans.
• Establish governance, guidelines, and communication channels; ensure supplier quality systems and documentation meet regulatory requirements and follow up on inspection responses.
• Coordinate with QA for annual quality management review and periodic TPM audits; ensure deviations are investigated and product dispositions are timely; track performance metrics.
• Develop, implement, and manage programs/projects including scope, cost, time, resources, communication, and risk management throughout initiation, planning, and execution.

Qualifications

• Bachelor‚Äôs Degree, preferably in science or technical field; MSc or MBA preferred.
• 10+ years of experience in manufacturing, engineering, project management, quality, and S&T.
• Broad business perspective with knowledge of manufacturing processes.
• Strong project management skills and ability to influence others; experience managing subcontracted relationships preferred.
• Proven leadership with excellent communication skills.
• Strong strategy development and planning skills with knowledge of pharmaceutical development, manufacturing, and supply.
• Strong problem identification and solution development abilities.
• Team-oriented, capable of working in a global environment.
• Strong knowledge of business financial systems and tools.

Skills

• Strategic planning
• Stakeholder management
• Quality systems and regulatory compliance
• Project management
• Forecasting and supply planning
• Financial planning and analysis

Education

• Bachelor‚Äôs degree in science or technical field; advanced degree preferred

Additional Requirements

• None beyond those listed; travel and physical demands not specified as essential