Eli Lilly and Company · 8 hours ago
Sr. Director - Quality for Business Development
Indianapolis, IN
Full-time
Hybrid
Director/Executive
$156K/yr - $229K/yr
10+ years expEli Lilly and Company is a global healthcare leader dedicated to improving lives through innovative medicines. The Sr. Director of Quality for Business Development will oversee quality activities for inbound and outbound innovation, ensuring compliance and excellence in the contracting process while collaborating with various teams to drive strategic growth.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Closely partners with other Process Owners, functional leaders, subject matter experts (SMEs), Quality, External Sourcing, Procurement, Compliance and Legal to define applicable compliance and business requirements, and to design efficient and compliant processes that utilize risk management principles
Leverages drug development expertise, commercial manufacturing and knowledge of internal and external requirements, industry best practices and benchmarking, new capabilities, and advances in technology including information flow to influence operational strategy and design processes that meet overall GQAAC quality audit and compliance program performance objectives
Evolve processes to match the changing business processes to ensure clarity of process inputs, outputs, and dependencies (e.g., connected processes, data standards, information flow implications, etc.), and role accountability for critical steps and decisions
Corporate Quality representative on the Corporate Strategy and Business Development (CSBD) Linkage Hub
Performs quality system maturity, compliance history and regulatory compliance risk profiles
Evaluates comprehensive assessment of potential acquisitions, and licensing opportunities and delivers clear, actionable recommendations to inform deal decisions
Provides quality support for each External Innovation due diligence project and coordinate completion and networking of all GCP, GLP and GMP reports to quality management and others as appropriate, including a consolidated quality focused risk summary for the project if necessary
Represents quality in kick off and information gathering External Innovation due diligence meetings and represents appropriately networked quality opinions in alignment and integration meetings
Participates in External Innovation due diligence site visits / eData rooms and subsequent audits as appropriate
Escalates significant concerns noted in business development due diligence activities to senior management following a risk-based considerations
Assures and partners with the appropriate quality area Subject Matter Experts (SME) is involved in each business development due diligence activity to include GCP, GLP and GMP as appropriate. This may also include working outside of GQAAC and outside of Lilly (i.e., consulting firms) to identify expertise appropriate to the specific due diligence
Serves as a liaison and provides quality and compliance insights during negotiations to the commercial business development team to ensure that Quality is represented in business deals related to purchase of new facilities
Reviews and provides quality perspectives / comments for contracts resulting from new business development opportunities and new line additions associated with existing collaborations, etc
Qualification
Required
Bachelor's Degree in a science-related field
Deep knowledge of global regulatory frameworks (FDA, EMA, ICH, etc.)
Strong business acumen and ability to influence at senior levels
Exceptional analytical, negotiations and communication skills
Proven ability to synthesize information from multiple sources and make risk-based decisions
Skilled in cross-functional collaboration and integration planning
A minimum of 10 years of experience in auditing, overseeing auditing, and/or regulatory inspections
A minimum of 10 years of experience in relevant GXP areas or associated supporting functions
Proven experience of merger and acquisition, strategic partnership and overseeing vendors/Third Party Organizations within the pharmaceutical/biotech industry
Successful track record at senior management level
Ability to work in a dynamic environment and deal with complexity
Preferred
Demonstrated ability to drive and lead cross-functional change
Experienced in multiple facets of drug development and/or pharmaceutical project management experience
Benefits
Company bonus
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (404)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2025-12-30
2025-12-30
Company data provided by crunchbase