Director - Global QC Sourcing Strategy

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

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

This position supports the global QC platforms. These platforms consist of 15 internal sites and multiple external partners. The network portfolio includes 10 marketed product families, 8 global launch programs and an advancing pipeline of over 13 new products. This complex network requires involved review of analytical capacities and siting.

Responsibilities:

• Collaborate with Mfg Strategy, AQCO (Global Quality Analytical Science and QC Operations), and other stakeholders to develop commercial sourcing strategy for analytical testing, in alignment with molecule/product strategy.
• Partner closely with AQCO and QC operations globally to assess capability, capacity, and timing of method installations to inform sourcing proposals for analytical testing (either at internal QCL’s or at external labs)
• Collaborate with Mfg Strategy, AQCO, and affected sites/functions to communicate commercial sourcing strategy and define associated resource and cost implications.
• Optimize a process for implementing analytical siting decisions.
• Refine processes for governance of proposals to outsource testing for existing products involving registered DS or DP release/stability testing from QC laboratories
• Implement a formal process to communicate to key business partners when MLT sourcing decisions have been made for analytical testing
• Establish processes of integrating testing from external third parties into internal QC laboratories post initial siting decisions.
• Develop and sustain capacity model for QC, leveraging Lab Planning and Scheduling tools accordingly
• Work with QCL in the development of the capacity model for the different laboratories
• Use capacity model to develop BP scenarios and provide input to improve/optimize capacity and utilization in QCL.
• Use capacity model to define overall project scope and equipment set needed.
• Implement an improved process for creation/maintenance of Supply Chain Maps to incorporate analytical testing sites throughout the lifecycle of our products
• Provide project plan assistance for key strategic plan initiatives for the site to ensure compliance and drive productivity. This includes working to help deliver the site’s facilities master planning and site productivity initiatives.
• Participate as QC user representative on key capital initiatives
• Participate in the design reviews and identify the applicable requirements.
• Assist the areas in completing the Operational Readiness exercise.
• Participate in Project Teams and /or assure there is QC representation.
• Facilitate the annual preparation of a Strategic Plan and a Business Plan for the global QC organization.
• Collaborate with and prepare materials for a broad spectrum of stakeholders, including Joint Analytical Governance Team, Manufacturing Sites, Manufacturing Lead Team (MLT), Development, corporate groups, Business units, and external parties.

Basic Requirements:

• Bachelor’s required (or equivalent) in scientific/engineering discipline.
• 5 years of industry experience (QC preferred)

Additional Skills/Preferences:

• Strategic thinking, learning agility, analytical skills, and ability to prepare complex analysis
• Extensive experience in leading laboratory and quality organizations
• Effective diagnosis of needs, action planning, implementation, and a bias for action
• Demonstrated ability to lead in a cross functional environment and deliver operational improvement
• Demonstrated ability to communicate with and influence across a broad range of levels, functions, and stakeholders
• Thorough knowledge of cGMPs and Quality systems with demonstrated technical proficiency
• Ability to effectively manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audience types
• Demonstrated ability to manage projects
• Preference for experience/familiarity with multiple manufacturing technology platforms (API, drug product, device)
• Preference for experience with both marketed products and commercialization (analytical development, control strategy, CM&C registration package) for new products
• Knowledge of analytical commercialization activities
• Understanding of IT systems

Additional Information:

• The normal schedule for this position is Monday-Friday, 8 hours/day.
• Some global travel is required with this position to support global sites.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
• This position is based out of our corporate center in Indianapolis, IN

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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