Sr. Director - Quality for Business Development

BioSpace; Indianapolis (IN); On-site; USD 156,000 - 228,800; Full time

Benefits offered by this job

401(k) and pension

Medical, dental, and vision benefits

Tuition assistance

Flexible benefits

Job summary

A leading healthcare organization in Indianapolis seeks a Sr. Director - Quality for Business Development. This key role oversees quality activities within the innovation sector and ensures compliance with global regulatory frameworks. The ideal candidate should possess a Bachelor's degree in a science-related field, with at least 10 years of experience in auditing and regulatory inspections. Strong negotiation, analytical, and communication skills are essential, alongside proven expertise in merger and acquisition processes. Competitive compensation and benefits package included.

Qualifications

• Minimum 10 years of experience in auditing and regulatory inspections.
• Deep knowledge of global regulatory frameworks like FDA, EMA, and ICH.
• Proven experience in merger and acquisition processes.

Responsibilities

• Oversee Quality activities for innovation, supporting enterprise strategy.
• Partner with various stakeholders to define compliance and business requirements.
• Evaluate and provide insights during business development negotiations.

Skills

Analytical skills

Negotiation skills

Communication skills

Cross-functional collaboration

Business acumen

Education

Bachelor’s Degree in a science related field

Job description

Sr. Director - Quality for Business Development

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 put people first and are looking for people who are determined to make life better for people around the world.

Key Objectives & Deliverables

This role oversees Quality activities for both inbound and outbound innovation, supporting an important aspect of enterprise strategy, innovation, and portfolio management. The Sr. Director will work closely with GQAAC Management and partner with executives, senior management, and functional leaders across Lilly Research Laboratories, Business Units, Product Research & Development, Procurement, and others.

Quality Process Owner for Business Development

• Closely partners with Process Owners, functional leaders, SME, 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 to influence operational strategy and design processes that meet overall GQAAC quality audit and compliance program performance objectives.
• Evolve processes to match 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 Linkage Hub.
• Performs quality system maturity, compliance history and regulatory compliance risk profiles.
• Evaluates comprehensive assessment of potential acquisitions, 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, 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 consideration.
• Assures and partners with the appropriate quality area SME is involved in each business development due diligence activity to include GCP, GLP and GMP as appropriate, and may also include working outside of GQAAC and outside of Lilly, 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.

Minimum Requirements

• 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, negotiation, 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.

Additional Preferences

• Demonstrated ability to drive and lead cross‑functional change.
• Experienced in multiple facets of drug development and/or pharmaceutical project management.

Education Requirements

• Bachelor’s Degree in a science‑related field, advanced degree preferred.

Other Information

• Domestic and international travel is required to fulfill these job responsibilities. Must be able to travel up to 20%, sometimes on short notice.

EEO & Accessibility Statement

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 here for further assistance. 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.

Compensation & Benefits

Full‑time equivalent employees will receive an annual base salary in the range of $156,000 – $228,800, with additional company bonus potential. Eligibility for a company‑sponsored 401(k); pension; vacation benefits; medical, dental, vision and prescription drug benefits; flexible benefits; life insurance and death benefits; tuition assistance; Employee Assistance Program; fitness benefits; and other employee clubs and activities are available to eligible employees. The anticipated compensation will vary based on experience, education, and geographic location.