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.

The Advisor - QA - Global Quality Systems (GQS) will establish Lilly's Quality Systems, which include Lilly Global Quality standards, business processes and IT tools. As a global expert, they consult with and educate customers on quality issues, and proactively ensure compliance of Lilly's Quality Systems with various country agency standards, industry trends and scientific principles to assure that all aspects of the operation are in compliance with regulatory expectations and Lilly quality standards. The Advisor – Global Quality Systems is responsible for monitoring the performance of the quality system and driving continuous improvement in the area of Drug Substance (API) and Dry Products for Lilly’s Manufacturing of Drug Substance and Drug Product.

Key Objectives/Deliverables:

• Manage documents supporting the Lilly Quality System (e.g., standards, practices, and resource documents within GQS) that govern activity in business areas such as Production Practices, Cell Banking, and other associated topics. Develop and provide education, training and implementation tools to promote consistent processes.

• Provide consulting support to business areas on interpretation and implementation of Lilly global quality systems.

• Maintain knowledge of current industry trends (including involvement in industry groups / conferences) and regulatory agency interpretation of cGMP requirements. Provide understanding of GxP requirements and their application and influence regulatory standards.

• Lead and/or support the assessment, development and implementation of global quality projects in support of continual Global Quality System improvements.

• Partner with sites to assure inspection readiness for the applicable quality systems and assist with related responses. Determine and implement global actions from site inspection observations and trends.

• Host communities of practices to drive stakeholder involvement, enable consistent execution at the sites, and share best practices, and understand execution challenges across sites.

• Drive needed improvements through monitoring of key process indicators across sites, trends, audit and inspection activity, industry practices, and the external environment.

• As a subject matter expert, directly interact with health regulatory authorities during inspections and draft responses to observations as needed.

• Consult with site(s) QC/QA to resolve related quality compliance issues. Serve as mentor/coach for local process owners for applicable quality systems.

Basic Requirements:

• Bachelor’s Degree in scientific field (e.g., Chemistry, Bio-chemistry), engineering, or related field

• Minimum of 10 years' experience in a cGMP environment with strong knowledge of quality systems

• Experience in Active Pharmaceutical Ingredient manufacturing.

• Previous regulatory inspection readiness and inspection execution experience

• Proficient with the usage of the MS Office suite (e.g. Word, Excel, PowerPoint, Access, Project, Visio).

Additional Skills/Preferences:

• Experience in the following quality systems:

• Process and Equipment Validation

• Quality Risk Management

• Drug Substance Manufacturing

• Non-sterile Drug Product Manufacturing

• GMP Utilities

• GMP Cleaning

• Detailed knowledge of European GMP’s, ICH, PIC/S, and WHO

• Continuing education / master’s degree or higher in science related field (e.g., Chemistry, Bio-chemistry).

• Previous facility or area start up experience, including equipment and process validation support.

• Demonstrated ability to interpret and apply standards to different situations by understanding customer needs and applying good problem-solving skills.

• Proficiency in planning and carry out tasks with a great degree of independence, and as part of a team, with minimal supervision and ability to travel.

• Demonstrated ability to communicate and deliver constructive feedback to customers, including oral, written and presentation communication skills.

• Demonstrated ability to develop business presentations and effectively communicate the concepts to a multiple range of personnel.

• Previous experience with cell cultures, chromatography, and tech transfers strongly preferred.

Additional Information:

• Ability to travel (5-10%) to sites, or conferences/external training courses/association meetings

• Requires visits to manufacturing sites.

• This is a flex position though must be able to be based at a Lilly facility (Indianapolis, IN, Lebanon, IN, RTP, NC, Concord, NC, Branchburg, NJ, Kinsale, Ireland, Sesto, Italy, Fegersheim, France) with flexibility for some remote work.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

#WeAreLilly