Manager, Product Quality

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.

Centessa Pharmaceuticals, a wholly subsidiary of Eli Lilly and Company is advancing a portfolio of high conviction programs with strong biological validation.  Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation.  Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses.

We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.

** Position Overview*
* Manager of Product Quality will oversee product quality activities across development and commercial-stage products, ensuring quality performance, compliance, and continuous improvement throughout the product lifecycle.

** Responsibilities*
* + Serve as Product Quality Lead for assigned program(s).

+ Investigate and finalize reporting activities for potential product complaints

+ Support Clinical Operations as required in the evaluation of product temperature excursions

+ Support manufacturing campaigns and release activities.

+ Ensure archival for expedient retrieval of key manufacturing documentation

+ Review deviations, investigations, CAPAs, and change controls for adequacy.

+ Analyze and report on product quality trends

+ Facilitate the development of risk assessments and mitigation activities and perform routine risk monitoring activities.

+ Partner with Technical Operations, Supply Chain, Regulatory Affairs, and Manufacturing teams to support regulatory submissions.

+ Support inspections and audits.

** Basic Requirements:*
* + BS/MS in Life Sciences.

+ 5-10 years pharmaceutical quality experience.

+ Knowledge of GMP manufacturing and quality systems.

** Additional Preferences**  **:*
* + Adaptive problem solver - turn issues into opportunities and translates ideas into solutions, even when the path isn't clear.

+ Leverage technical depth and a growth mindset to make impact; imagine what's possible and pursueit with intention and energy.

+ Demonstrate curiosity and drive self-identified innovation, especially in the exploration of artificial intelligence and digital.

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 (  ) 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…