Operations Director- External Manufacturing- Americas (Project Management)

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Your Role: Operations Director- External Manufacturing- Americas

EEM-AM is the Elanco External Manufacturing hub responsible for managing contract manufacturers in the Americas region. This position plays a critical role in the support of reliable product supply by being responsible for the performance of a portfolio of Injectables contract manufacturers. This role will have significant responsibility for all aspects of product supply from these Contract Manufacturers (CMs). This includes executing appropriate governance and ensuring that appropriate levels of service and compliance are met. The Operations Director is a member of the Elanco External Manufacturing- Americas (EEM AM) Lead Team.

Your Responsibilities:

• Contract Management: Responsible for working closely with functional leadership in the definition of contract terms and negotiation strategies. Represent EEM-AM by assisting procurement with the negotiation of new contract manufacturing contractual arrangements and renewals. Provide on-going oversight for ensuring site compliance with contractual arrangements.
• Responsible for monitoring and influencing all functional activities associated with product supply from the CMs; driving collaboration between functional areas / Process Teams (e.g. Planning/Scheduling, TSMS and Quality) to resolve issues and ensuring reliable product supply and product quality in a cost-effective manner. Governance will include oversight of a balanced scorecard in accordance with EEM standards. Responsible for the adherence to appropriate financial, quality, supply chain, HSE, regulatory, internal standards as well as internationally recognized standards at external manufacturers. Direct people leadership and Performance Management responsibilities for supply chain and operations employees.
• Relationship Governance: Responsible for forming, facilitating, and leading the appropriate governance structure in accordance with EEM standards, including the establishment of steering teams, joint process teams, setting relationship goals and success indicators, driving continuous improvement activities and overall monitoring of performance.
• Participate in CM selection and due diligence activities driven by global business development and the requirement for new product launches. In addition, Responsible for completing periodic reviews of CM relationships against set goals and objectives; recalibrating expectations as appropriate and conducting periodic risk assessments of CMs while communicating results to senior management.
• Technical Transfers: Responsible for supporting successful technical transfers either into or from contract manufacturers. Ensuring that supply remains undisrupted throughout any technical transfers or terminations.
• Warehousing and logistics: Responsible for ensuring alignment of materials needs with CMs, working closely to ICOs team to ensure appropriate delivery to the affiliates and close connection with Inventory Management team to ensure GRs, supporting invoice entries, material consumptions and products transfer to affiliates.
• PCAPs: Review and approve PCAPs related to Injectables portfolio and support management of all the change requests that affect products manufactured, ensuring alignment among all involved areas and proper implementation according to the approve.

What You Need to Succeed (Minimum Qualifications):

• Education: Engineering or Science degree (B.S. or higher)
• Required Experience: 5-7 years' experience in a cGMP manufacturing environment
• Skills: Previous successful supervisory experience and a good understanding of supply chain methodology and concepts
• Ability to influence others to obtain business results

Additional Preferences:

• High communication skills
• Excellent mentoring and coaching skills
• Proficiency with computer systems including SAP, Veeva, Microsoft Office, etc.
• Knowledge of external manufacturing environment  
• Ability to influence others to obtain business results

Other Information:

• Travel: 20-30%. Position requires domestic and international travel.
• Location: Greenfield, Indiana- Elanco Global Headquarters, Hybrid Work Environment

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status