External Manufacturing Operations Director

Job Description

External Manufacturing Operations Director

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. We are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Join our team and contribute to our mission of using leading-edge science to save and improve lives around the world.

The External Manufacturing Operations Director provides strategic and operational leadership for products manufactured by external partners supporting the Simtra site in Bloomington, IN. This role is accountable for ensuring reliable, high quality, and compliant supply by overseeing production planning, materials management, quality and technology issues, and day-to-day manufacturing performance. Acting as the primary operational interface with external manufacturing partners, the Ops Director leads issue resolution and escalation, ensures appropriate oversight‑ of shop‑floor activities, and drives continuous improvement initiatives to enhance efficiency, quality, and supply reliability across the network.

Responsibilities

• Provide leadership in dispute resolution with appropriate escalation
• Oversee production planning and materials management (SAP entries, E2E Planning, Logistics)
• Manage quality issues including deviation management, product release, and change control
• Address technology issues such as technology transfers, investigations, and process improvements
• Supervise shop floor production and determine when an ExM Quality or Technology representative should be deployed to the External Party’s facility
• Lead MPS and continuous improvement activities
• Partner with ExM leaders in functional areas (e.g., Procurement, Quality, Technology, Finance, Legal, HR) to address broader business issues, customer needs, and opportunities
• Participate in the annual profit planning process and provide monthly estimated actuals on projected and actual spending
• Maintain a multi-year capital plan/budget
• Handle people-related matters including staffing, employee development, performance & compensation management, employee relations, and retention
• Create and maintain a high-performance team organization and culture
• Ensure External Party capacity information is provided for robust end-to-end planning activities
• Create and maintain an External Manufacturing Organization Handbook containing Global ExM policies, procedures, templates, etc.
• Facilitate EM Operations Manager collaboration to leverage best practices and lessons learned across ExM Ops
• Participate in periodic Business and Relationship Review Meetings
• Serve as a member of applicable Value Chain Management Teams to reduce overall cycle time, inventory, and support life cycle management activities
• Represent ExM Org on applicable Tactical Ring and/or Business Leadership Teams (Pharm, Chemical, and Sterile)
• Stay abreast of industry and policy changes and identify implications and opportunities for ExM and/or ExM Organization at large

Qualifications

Required

• Bachelor’s degree in Engineering, Science, or Business; Master’s degree preferred.
• A minimum of ten (10) years’ experience in commercial, business, and/or manufacturing (within experience in operations, quality, technology, planning, procurement) function
• Excellent interpersonal, communication, collaboration, negotiation, and project management skills
• Demonstrated strong leadership, managerial, problem-solving, and team-building abilities
• Sensitivity to diverse cultures
• Ability to work independently with minimal coaching
• Decisive in ambiguous environments
• Able to represent our company to the external party

Required Skills:

API Manufacturing, Biotechnology Manufacturing, CMO Management, Contract Management, Cross-Cultural Awareness, Cross-Functional Project Management, Dispute Resolution, Driving Continuous Improvement, External Manufacturing, Financial Acumen, Global Experience, Manufacturing Technologies, Medical Device Manufacturing, People Leadership, Proactive Thinking, Production Planning, Production Scheduling, Quality Systems Design, Risk Mitigation Strategies, Sterile Manufacturing

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, e