Quality Assurance Operational Support

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply.

This is an exciting opportunity to help start up a state-of-the-art facility and build a manufacturing supply chain from ground-up.

Position Overview:

The Quality Assurance Operational Support Representative is responsible for demonstrating leadership, teamwork, and quality/regulatory knowledge to provide oversight for the delivery and daily operation of the Lilly Advanced Therapies (LP2) site. The QA Operational Support Representative provides guidance to issues such as non-conformance investigations, change control proposals, procedure / master formula revisions, validations, batch disposition, commissioning, and qualification activities. The Quality Assurance Operational Support Representative is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies.

Responsibilities:

• Adhere to safety rules and maintaining a safe work environment for both you and others by supporting HSE corporate and site goals

• Provide technical and quality review and approval of documents to ensure compliance with Lilly Global Quality Standards and local procedures

• Oversee verification of manufacturing equipment/facilities from definition of requirements thru design and testing

• Lead, mentor, and coach operations and support personnel on quality matters, e.g. good documentation practices, data integrity and regulatory compliance.

• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group

• Support the definition and execution of inspection readiness activities and provide support for internal / external regulatory inspections

• Lead/support Process Team initiatives needed in support of the Site and Quality function

• Ensure regular presence in operational areas to monitor GMP programs and quality systems

• Provide guidance and triage for deviations and change controls

• Support and/or execute review of batch records and release of drug substance, drug product, and finished product batches for Clinical Trial and commercial use

• Consult with Network and Global quality groups as required to ensure consistent and compliant approach to facility delivery and operation

Basic Requirements:

• Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience.

• 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles.

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills/Preferences:

• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing

• Demonstrated ability to communicate with and influence cross-functional teams including good oral and written communication skills

• Demonstrated strong problem solving and decision-making skills

• Previous technical writing experience

• Technical aptitude and ability to train and mentor others

• ASQ Certified

• Experience with equipment verification and validation oversight including automation and computer systems validation.

• Previous facility or area start up experience.

• Previous experience with gene therapy drug substance processes such as equipment prep, virus prep/banking, inoculation, purification, and/or drug product manufacturing processes such as formulation, filling/visual inspection, and packaging.

• Proficiency with computer systems including Kneat, Veeva Vault, SAP, manufacturing execution systems, and Microsoft Office products.

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600

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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