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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$151,500 - $222,200

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 44,000 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.

Lilly is starting up multiple new Drug Product Parenteral manufacturing, device assembly, and packaging facilities to support patient demand. These facilities will provide medicine for current and future products.  To start these facilities with a strong safety, quality, and operationally excellent culture, the Quality Ramp Team Leader will be responsible for supporting all new parenteral pre-filled syringe, device assembly, and packaging lines at our new facilities by orchestrating subject matter experts to support the sites during key operational milestones with specific focus on building process team capability and achieving desired asset ramp rates.  RAMP stands for Rapid Acceleration of Medicine to Patients.

This is a unique opportunity to support global startup activities for state-of-the-art greenfield manufacturing sites, and the successful candidate will help ensure the effective start up, capability build, and efficient operational ramp of our lines and teams. 

OVERVIEW

The Senior Director, Quality – Global RAMP Team, will lead and deploy a team of quality experts who partner cross-functionally to support our new pre-filled syringe, device assembly, and packaging lines.  The RAMP team will specifically focus on building process team capability and streamlining, standardizing, and harmonizing processes to enable desired asset ramp rates. This entails active presence on the production floor providing real-time coaching and feedback to grow team capability. It also includes assisting the site with delivery of key quality capabilities (e.g., deviation writing, SOPs revision/review, batch review) through active process ownership and leadership to enable rapid ramp while fostering capability growth. The scope of this team begins when effectiveness has been demonstrated through each respective assets integrated qualification and continues through achievement and stabilization of desired asset ramp.  Success is ultimately measured by the respective site process team capability to achieve and maintain the target asset efficiency rate.       

This role will work closely with the Global Operational RAMP leaders for Parenteral and Device Assembly & Packaging, the local lead teams (site, flow, process) and global functions to achieve the key operational objectives.  This role will build and lead a team of regionally based functionally strong and operationally centered experts purely focused to efficiently supply medicine with safety first and quality always. 

Key Responsibilities

Key Responsibilities include, but are not limited to the following;

Build, develop, lead, and deploy a regionally based team of operationally centered player coaches to help the site achieve desired process team capability as measured by asset ramp rates.  This team starts where asset qualification ends.Maintain an active presence on the production floor providing real-time coaching and feedback to grow team capability.Assist the site with delivery of key quality capabilities (e.g., deviation writing, SOPs revision/review, batch review) through active process ownership and leadership to enable rapid ramp while fostering capability growth.Quickly escalate program delivery constraints and capability issues to senior leadership so remediation actions may be discussed and prioritized.The quality team will focus on Lilly’s pre-filled syringe, device assembly, and packaging platforms and will be comprised of the following process team capabilities:  Formulation (including equipment prep), Filling, Vision Inspection, Sterility Assurance, Materials, Quality Assurance, and Quality Control.   Partner with the Global Operational RAMP Leaders for Parenteral and Device Assembly and Packaging.Ensure adherence to cGMPs and Quality Management System requirements while partnering cross-functionally to efficiently supply medicine with safety first and quality always. Partner with relevant global functional leaders to leverage deep technical expertise and global functional support as needed. Connect and liaise with site leadership at new sites to ensure they have adequate support.Effectively communicate and manage internal and external stakeholders.Develop common tools and practices for site start-up activities to support future start-ups’ acceleration to operational readiness.Identify and forecast resource needs by start-up site and facilitate getting resources assigned. In addition to Lilly resources, leverage professional contract resources to scale support based on demand.Develop and present performance metrics to appropriate site and network governance forums.Work closely with network teams (e.g., PNO PFS, Global Packaging) to design the expected learning curve for operational lines and monitor progresses toward the target for the new lines during start-upHire and build a team of quality experts who are excellent in execution, are process-minded, and are excellent peer coaches.

Attributes for the Role

Demonstrated experience at baseload parenteral manufacturing, device assembly, and packaging site(s).  A desire to expand skills and influence across multiple networks.Demonstrated technical breadth managing multiple aspects of the Quality Management System (e.g., deviations, change management, batch disposition, QA floor program, QC operations, environmental monitoring).Demonstrated experience working on process and flow teams.Demonstrated project management and delivery of medium to large scale cross-functional initiatives.Demonstrated ability to manage in a dynamic environment. Flexibility to adjust quickly and effectively to frequent change and altered priorities.Demonstrated ability to input and influence decision making for complex issues.Demonstrated ability to navigate ambiguity.Excellent self-management/organizational skills; manage workload, set team priorities and adjust.Ability to interact with multiple functions (e.g., Technical Services, Engineering, QA, QC, IT, Operations) and combine work streams into an integrated schedule. Demonstrated ability to influence peers and business partners.Strong interpersonal and teambuilding skills; able to develop effective teamwork between team members with diverse interpersonal styles.Ability to manage remote teams in multiple geographies.Strong ability to coach employees to perform at a high level and to build their skills.

Basic Requirements

Minimum of a Bachelor's degree (or equivalent) in a relevant discipline (Engineering/Science)10+ years of experience in a functional or operational leadership role within the pharmaceutical industry.Must possess knowledge and understanding of cGMPs and how they apply to manufacturing operations.Should have a demonstrated track record of successfully running and improving asset efficiency.

Additional Skills/Preferences

Experience in site/asset start-up activities.Experience leading a quality team.Experience in cross-cultural communication and influence without authority.

Additional Information

Flex hours possiblePrimary location is Indianapolis, IndianaAbility to travel (approximately 40-50%) travel to the new parenteral startup sites

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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