Principal Associate

1 month ago

Indianapolis, Indiana, United States Eli Lilly and Company Full time

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.

Position Brand Description:

Drug Product External Manufacturing (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of North, and South American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. DPEM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.

The QA Lead for contract manufacturers (CMs) provides daily oversight, assistance, and guidance to issues such as deviation investigations, change control proposals, procedure/ master formula revisions, validations and other duties associated with daily CM activities. This role provides and assures compliance to Lilly GQS by resolving identified procedural gaps and is responsible for assuring the CM maintains a state of control with regards to manufacturing, Device assembly and/or packaging product. The QA Lead is integral for maintaining GMP compliance and providing support during preparations for Pre-Approval/ General inspections by various agencies. The QA Lead is integral for launching new products, packages, processes, and CM's.

Key Objectives/Deliverables:

Lead/ provide support to launch new products/ packages/ CMs.Provide guidance and quality oversight of CMs manufacturing, Device assembly and packaging, the batch disposition process and maintenance/improvements of their quality systems.Evaluate issues, deviations, change controls and disposition batches countermeasures.Participate on Joint Process TeamsOriginate and investigate deviations associated with batch records and other DPEM activities.Work with Lilly support groups to resolve product related issues.Provide final approval of Certificates of Analysis or other similar documentation for internal and external customers.Provide support on site or remotely during inspections and maintain awareness of internal audit findings and external regulatory agency inspections.Provide assistance and guidance in Standard Operating Procedure revisions, Master Batch Record revisions, Master Packaging Order revisions and Process ValidationsReview and approve documentation that supports manufacturing (e.g., deviations, changes, procedures, protocols), as applicable.Author and track compliance to the CM Quality Agreements and CM Quality PlansRoutinely have face-to-face communications with CMsTrack and monitor Quality metrics for trends at the CMSupport Qualifications/ Validation document creation and reviewsProvide and coordinate designated sections for Annual Reports and Annual Product ReviewsExecute SOP assessments of CMs and track completion of outstanding issuesProvide support for Notification to Management data gatheringProvide input for metrics reports to managementEstablish, maintain, improve, and monitor effectiveness of DPEM Data integrity programEnsure compliance to DI guidelinesComplete other duties as assignedBasic Requirements:At least 5 years of experience in pharmaceutical or medical device manufacturing/qualityBachelor's Degree in a science related field such as Engineering, Pharmacy, Chemistry, Biological Sciences or related Life Sciences or equivalent experienceAdditional Preferences:Proven ability to work independently or as part of a Team to problem solveExperience with Lilly electronic systems (SAP, Trackwise, Regulus) and computer system validation.Experience with DI for drug product manufacturing and packaging processesAbility to conduct GMP activities.Experience developing and maintaining specification systems for raw materials, components, drug product, and finished product.At least 5 years' experience directly supporting a manufacturing and packaging operations.Proficiency in leading root cause investigations and self-inspectionsProject management skillsCoaching and mentoring skillsTechnical understanding of cGMPs and the Global Quality StandardsKnowledge of Pharmaceutical Manufacturing OperationsStrong written and verbal communication skillsTeamwork and interpersonal skills exhibited across functional areasAbility to organize, prioritize, multi-task, and influence diverse groupsStrong decision making and problem solving skillsOther Information: Shift is days, but off-hours may be necessary to support operationsDomestic and International travel is possible, 10 – 25%Position is required to be onsite at Lilly Corporate Center the majority of the time. 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 ( ) 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

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