Operations Primary Loop

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Responsibilities**

This role is responsible for all activities related to the support of external manufacturing as defined in the Global Contract Manufacturing Standards.

This role is a member of the joint process team (JPT) and has direct responsibility for oversight of the day-to-day operations at the CM.

**This role will be a person in plant at a CM based in Latina (ITALY) Parenteral Manufacturing site.**

**Key Objectives/Deliverables**:

- Define operational excellence roadmap and support CM in the implementation to improve safety, quality and productivity
- Invest time on the shop floor to ensure practices are matching local procedure. Identify and promote operational best practices on the floor and set Lilly expectations.
- Establish and promote human error prevention program, tracking metrics and CM overall performance
- Transfer operational knowledge to the CM to minimize recurrent deviations ensuring flawless execution on the floor
- Support on-going CM Operations by providing operational oversight at the Joint process Team as Primary Loop support
- The Operations PiP. as a Person in Plant and as a member of the Joint Process Team should be the facilitator of the communication between the CM and the JPT, including:

- become the primary contact person for the JPT, supporting the JPT Leader for escalation and issue management
- Spend time on the floor to understand unit operation and the CM technology and monitoring line performance.
- Spend time during Lilly product is running in the manufacturing/assembling/packaging lines.
- Having a holistic understanding/knowledge of the product/process, and its associated equipment, facilities, computer system and operations.
- Defining, understanding, and owning the process control strategy including the key process parameters, critical quality attributes.
- Understanding product history and potential failure modes of the process.
- Contribute to identify and implement Continuous Improvement and Operational Excellence projects at the CM
- Support JPT members to monitor the Technical Agenda identified at CM
- Manage conflict and problem resolution.
- Assist to the CMs on the preparation of any audit from Lilly (GQAAC) or any external agency that impact Lilly products.
- Translating process requirement and education to the Joint Process team members.
- The Operations PiP as a Person in Plant should provide support to the management of daily operations including:

- Support JPT members on deviations and complaints management facilitating the interface between Lilly and the CM
- Assist to JPT members supporting the CM on periodic documents preparations and presentation delivery
- Support the root cause analysis process in case of deviations or complaints collaborating with CM SME (shopfloor presence)
- Ensuring planned changes and deviations are managed appropriately. Respond in a timely manner and accurately to requests for information.
- Proving trouble shooting support and maintaining awareness of issues & progress their resolution ensuring that JPT members and senior management are notified through approved escalation procedures.

**Relationship with CMO**:

- Identify training needs with the External Manufacturer. Arrange and conduct training if necessary.
- Inform properly and in a timely manner to JPT Leader about quality issues, product delivery risks, etc. Identifying issues root case and recommended action plans to solve them and avoid recurrences.

**Department Initiatives**:

- Maintain regular communication with management through effective participation in Routine governance meetings.
- As a team member, actively participate and contribute to the Joint Process Team objectives.
- Provide input in monthly reports and metrics through the JPT.
- Actively pursue opportunities for continuous improvement (both process and procedural).
- Model of Safety behaviors.

**Relationships**:

- All functions at the contract manufacturers from senior management to shop floor personnel.
- Lilly Affiliate personnel and senior Country and Area management (if required).
- Lilly Ops, Supply Chain, TS/MS, QA, Auditing groups, Laboratories at Lilly sites.
- All relevant functions at the Lilly IHL (if required).
- Senior Ops management, Lead team members, etc

**Basic Qualifications**
- Education:

- Bachelor's Degree or equivalent work experience in Pharmacy, Chemistry, Engineering, or similarly related fields.
- Experience: