Director, External Quality Control & Stability

BioSpace; Indianapolis (IN); Remote; USD 117,000 - 260,000; Full time

Job summary

Lilly, headquartered in Indianapolis, is seeking a Director, External Quality Control & Stability, to lead analytical quality oversight across programs. This remote US role offers the chance to drive regulatory-compliant stability activities and supplier oversight in a fast-paced environment.

You will review methods, support transfers, and guide stability strategy, partnering with cross-functional teams to ensure product quality and timely submissions.

Qualifications

• BS/MS/PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field.
• 10+ years quality control and analytical development experience.
• Experience developing strategic vision with tactical support for QC programs.

Responsibilities

• Analytical oversight and tactical support across multiple programs.
• Review analytical methods, specifications, and validation activities.
• Support analytical method transfer as required.
• Collaborate on supplier qualification and remediation activities.
• Oversee the stability program design and execution.
• Ensure regulatory compliance of stability activities.
• Provide regulatory support for submissions and inspections.
• Review analytical and stability sections within CMC filings.

Skills

Quality control leadership

Analytical development

Regulatory submission support

Supplier oversight

Program oversight

Education

BS/MS/PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field

Job description

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.

Overview

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical‑stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep‑wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical‑stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.

Responsibilities

Analytical Oversight and Tactical Support

Develop and Lead analytical quality control strategy across multiple programs.

Review analytical methods, specifications, and validation activities for adequacy and collaborate on updates, as required.

Support analytical method transfer, as required

Collaborate on supplier qualification and/or remediation activities.

Stability Program Leadership

Oversee the stability program design and execution across multiple programs.

Monitor and report on stability trends and product quality attributes as required.

Ensure ongoing regulatory compliance of stability activities.

Supplier Oversight

Manage supplier ongoing relationships.

Perform routine reviews of testing results and overall quality of documentation.

Drive issue resolution to facilitate regulatory compliance.

Regulatory Support

Provide tactical support for regulatory submissions

Support health authority inspections and audits, as required.

Review analytical and stability sections within CMC filings.

Basic Qualifications

BS/MS/PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field.

10+ years quality control and analytical development experience.

Experience developing strategic vision as well as providing tactical support for quality control programs

Work Location

The Director, External Quality Control & Stability role is a remote role based in the US.

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

$117,000 - $259,600

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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