Director - quality and therapy

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 give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Purpose

The purpose of Sr Director – Medicines Quality Organization (MQO) is for the design, implementation, and execution of a medical, regulatory, and safety quality system to support the evolving cell and gene therapy landscape. This role is responsible for quality assurance, quality risk assessment and mitigation, continual quality improvement, assessment and implementation of external regulations and inspection readiness. The Sr Director will manage extensive interfaces with the cell & gene therapy discovery & research organizations across rapidly expanding product development and manufacturing capabilities and sites as well as corporate quality teams. This Sr Director will operate across many corporate functions including Global Patient Safety (GPS), Global Regulatory Affairs (GRA), Clinical Design, Delivery and Analytics (CDDA), Manufacturing, MQO, Global Quality Assurance Auditing & Compliance, Legal, and Ethics and Compliance; and third-party organizations (TPOs). The Sr Director will seek to understand and define the Medicines Quality landscape across this rapidly expanding area.

Quality Leadership

The Sr Director is responsible for partnering with Cell & Gene Therapy Senior Management within discovery, research, product development and manufacturing as well as Medical, GRA, GPS, Data Sciences and Clinical Development on cell & gene therapy related matters to establish and sustain a “Quality in Design” approach to discovery research, product development, registration, and maintenance. This work will include partnering with wholly owned subsidiaries of Lilly. The Sr Director will design and lead the implementation of the SEQS Quality System to support cell & gene therapy across Medical, Regulatory and Safety and ensure operation in a manner such that all GCP/GVP activities are followed. The Sr Director is responsible to engage externally to monitor, benchmark, and gather innovative intelligence to influence internally and externally quality related topics related to gene therapy. The Sr Director is responsible for understanding and interpreting cell & gene therapy global regulations, requirements, and guidance as it evolves to ensure ongoing SEQS Quality System compliance. The Sr Director is responsible for ensuring development of quality education programs to support cross-functional integration, adoption, and utilization of the cell and gene therapy expectations into the business. The Sr Director is responsible to partner with key stakeholders to influence the application of cell & gene therapy requirements across applicable functional areas and quality systems. The Sr Director will partner with other members of MQO, Legal, and Ethics and Compliance to ensure alignment with Lilly Policies and evolving operational and quality strategies and initiatives. The Sr Director is responsible for providing quality leadership for the cell & gene therapy portfolio and partnering with Medical and Clinical Development functions in establishing appropriate support and oversight for each clinical development program, including sharing feedback for continuous improvement. The Sr Director is to ensure that Cell & Gene Quality and Clinical Development functions work in unison to ensure patient safety, data integrity and regulatory compliance. The Sr Director will establish relationships and partner with other Quality units (for example, Product Development and Manufacturing) to ensure seamless transitions of information and data where quality systems intersect. The Sr Director is responsible for establishing the appropriate level of quality integration with acquired gene therapy assets and wholly owned subsidiaries, supporting ongoing relationships.

Quality Risk Assessment, Mitigation, and Improvement

The Sr Director is responsible for the effective partnership between Medical/Clinical and Quality personnel to identify and mitigate performance gaps relative to Quality requirements and to evolve the overall Quality understanding of cell & gene therapy requirements. The Sr Director is expected to actively participate in forums to assure quality plans/goals/initiatives are identified and implemented, and to identify areas for further improvement.

Inspection/Audit Readiness and Management

The Sr Director ensures the necessary processes are being effectively implemented to prepare for and manage regulatory inspections, internal audits and third-party audits and responses to such activities.

Staffing Management

The Sr Director will partner with the MQO Systems leadership to determine appropriate resources and for recruiting, hiring, and potentially supervising the necessary Quality resources to fulfill the Quality needs of the growing cell & gene therapy portfolio.

Minimum Qualification Requirements

Bachelor’s degree in a relevant scientific or clinically related field or demonstrated equivalent. A minimum of 7 years of direct experience with GCP regulations, Quality systems, Quality issue resolution, and/or regulatory inspections

Or A minimum of 7 years of experience in clinical development and/or related areas Or A minimum of 7 years of experience in discovery/research technologies

Ability to travel 15-30% of the time as needed

Additional Preferences

Higher Level qualifications are preferred (e.g., Masters, PhD) Excellent communication (written and verbal), interpersonal, organizational and negotiation skills. Strong knowledge of quality systems if no direct quality roles held. Demonstrated ability to supervise others. Demonstrated decision making skills. Demonstrated ability to operate across boundaries (cross-functional and cross-company) and influence others. Strong problem-solving and communication skills (both written and verbal) Strong teamwork and interpersonal skills Self-management and motivational ability Customer focused, flexible/adaptable. Process improvement oriented.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly #J-18808-Ljbffr