Quality Assurance- Business Development

Regulatory Toolkit; Indianapolis (IN); On-site; USD 101,000 - 185,000; Full time

Benefits offered by this job

Company bonus

401(k)

Medical/dental/vision benefits

Vacation benefits

Well-being benefits

Life insurance

Job summary

Lilly in Indianapolis seeks a senior Quality Assurance professional for Business Development. The role supports asset and company acquisitions, conducts risk assessments, and ensures robust integration plans and quality strategies across programs.

The incumbent will lead quality on strategic projects, coach teams, and help negotiate and implement Quality Agreements within a fast-paced environment focused on patient impact.

Qualifications

• Bachelor’s degree required.
• Minimum of 10 years of Quality Assurance or related experience.
• Minimum 2 years’ experience in PR&D (business or QA).
• Authorized to work in the United States on a full-time basis; Lilly will not sponsor.

Responsibilities

• Identify risks and develop risk-based strategies and transition plans for acquisitions.
• Communicate PRD strategy and transition plans with quality leads at acquired companies.
• Deliver portfolio needs and manage quality-related issues with cross-functional teams.
• Provide coaching and education on quality requirements for acquisition processes.
• Support authoring, negotiation, and implementation of Quality Agreements.
• Author integration strategy documents, risk assessments, and change controls.
• Coordinate GMP activities for acquisitions with PRD Quality Management and Quality resources.

Skills

Project Management

Leadership

Communication

Quality Assurance

Vendor management

Cross-functional collaboration

Mentoring

Education

Bachelor’s Degree

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.

Position Brand Description:

The role of the Quality Assurance- Business Development is to support activities related to business development initiatives for asset and company acquisitions as well as licensing deals. The individual will complete risk assessments related to acquisitions and ensure appropriate risk mitigation is employed. This role will work with the Senior Director QA Business Development to ensure a robust strategy and integration plan is developed and executed for each acquisition. This individual will represent Quality on strategic projects related to acquisitions and may also support due diligence activities as needed.

Key Objectives/Deliverables:

Acquisitions

• Partner with business leads to identify risks, mitigations and develop a risk appropriate strategy and transition plan for acquisitions.
• Partner with Quality and key business leads at acquired company to communicate PRD strategy and transition plan and work to ensure a smooth transition for Quality‑related items.
• Work with cross functional team in PRD to deliver portfolio needs and manage Quality‑related issues as they arise
• Provide coaching and education to the business and Quality organization on quality requirements for the Acquisition process.
• Support the authoring, negotiation, and implementation of Quality Agreements as needed.
• Author Integration Strategy documents, risk assessments, and change controls as needed.

General

• Coordinate activities with PRD Quality Management and Quality resources to ensure timely execution of GMP activities for acquisitions.

Basic Requirements:

• Bachelor’s Degree
• Minimum of 10 years of Quality Assurance or related experience.
• Minimum 2 years’ experience in PR&D (business or QA)
• 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 Preferences:

• Project Management knowledge/experience
• Experience working with external parties
• Demonstrated leadership skills
• Demonstrated strong written and verbal communication skills
• Demonstrated ability to work in high pressure situations on tight timelines.
• Demonstrated ability to work independently and in a highly integrated team environment
• Demonstrated ability to coach and mentor others

Other Information:

• Up to 10% travel may be required

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

$101,250 - $184,800

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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