Associate Director, External Manufacturing - Aseptic

Role Summary

The Associate Director, External Manufacturing will be the primary supplier relationship contact responsible for organizing, supervising, and driving strategic initiatives and technical support to manage the supply of designated products. The role ensures high-quality product manufacturing in compliance with local and international regulations, and that products are released and delivered according to forecasts, schedules, and planned costs. It also manages programs to ensure a cost-effective, marketable, and manufacturable product, maximizing profitability over its life cycle, and coordinates operations for existing and new products manufactured with the supplier through matrix management of cross-functional teams.

Responsibilities

• Participate in the negotiation of the Manufacturing Service Agreement and amendments, and ensure compliance with the terms of the agreements.
• Ensure effective planning and material procurement strategies are in place to supply the TPM with the required materials.
• Communicate product forecasts to the TPM and agree on manufacturing and delivery schedules; coordinate with Supply Chain and Planning to ensure on-time delivery.
• Actively participate in the development of Financial Operating Plan, Updates, LRP, and standard processes, ensuring financial goals are met.
• Coordinate the Steering Committee and monitor that Virtual Operation Teams meet periodically to evaluate performance, address issues, and escalate when necessary.
• Review status reports and prepare updates for senior leadership.
• Collaborate with technical and quality teams to review process performance and quality trends and agree on improvement plans.
• Establish governance, guidelines, and communication channels; ensure the supplier has necessary quality systems and documentation to meet regulatory requirements and follow up on inspection responses and commitments.
• Coordinate with QA on annual quality management reviews and periodic audits of the TPM; ensure deviations are investigated and disposition decisions are timely; establish and track performance metrics.
• Develop, implement, and manage projects with scope, cost, time, resource management, communication, and risk management through initiating, planning, and executing phases.

Qualifications

• Bachelor’s Degree, preferably in science or technical field; MSc or MBA preferred.
• Minimum 10+ years of experience in manufacturing, engineering, project management, quality, and S&T; external manufacturing experience with aseptic manufacturing required.
• Broad business perspective and understanding of manufacturing processes.
• Strong project management experience and ability to influence others.
• Experience managing subcontracted relationships preferred.
• Proven leadership with superior communication skills (listening, verbal, presentation, written).
• Strong strategy development and planning skills with knowledge of pharmaceutical development, manufacturing, and supply activities.
• Excellent issue identification and problem analysis/solution development skills.
• Team-oriented, able to work in a globally oriented environment.
• Solid knowledge of business financial systems and tools.

Education

• Bachelor’s Degree required; advanced degree (MSc/MBA) preferred.