Associate Director, External Manufacturing - Aseptic

About This Role

This role will serve as the main supplier relationship contact for external manufacturing, managing designated product supply to ensure high quality production, regulatory compliance, and timely delivery. The Associate Director will also lead strategic initiatives and project management to maximize profitability throughout the product lifecycle.

Responsibilities

• Negotiate and ensure compliance with Manufacturing Service Agreements and amendments
• Ensure effective planning and material procurement strategies for Third-Party Manufacturers (TPM)
• Communicate product forecasts and agree on manufacturing/delivery schedules with TPMs
• Actively participate in financial planning (Operating Plan, Updates, LRP, Standard processes) and meet financial goals
• Coordinate Steering Committees and monitor Virtual Operation Teams for performance evaluation and issue resolution
• 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 compliance with regulatory requirements and follow up on inspections
• Coordinate annual quality management reviews and periodic audits of the TPM; ensure deviation investigation and product disposition
• Establish performance metrics and periodically track performance
• Develop, implement, and manage programs or projects including scope, cost, time, resource, communication, and risk management

Requirements

• 10+ years of experience in manufacturing, engineering, project management, quality and S&T
• External Manufacturing experience
• Aseptic experience in external manufacturing
• Broad business perspective and knowledge of manufacturing processes
• Strong project experience
• Leadership ability with superior communication skills (listening, verbal, presentation, written)
• Strong strategy development and planning skills
• Knowledge of pharmaceutical development, manufacturing, and supply activities
• Issue identification and strong problem analysis and solution development skills
• Demonstrated team player and ability to work in globally oriented work environment
• Strong knowledge of business financial systems and tools

Qualifications

• Bachelors Degree in science or technical related field. MSc or MBA degree is preferred.
• 10+ years of experience in manufacturing, engineering, project management, quality, and S&T, with required external manufacturing and aseptic experience.

Nice to Have

• MSc or MBA degree
• Previous experience managing subcontracted relationships

Benefits