Advisor - PR&D Quality Systems

Overview

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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The PR&D Quality System Sr. Director provides critical technical leadership, leads optimization of the PR&D Quality System to ensure continuous improvement, maintain compliance in a changing regulatory landscape, and network with new R&D facilities for Quality System Integration. In addition, the position involves networking and partnering with our Global Process Owners with respect to Clinical Trial Manufacturing.

• Responsible for technical leadership of PR&D Quality System as it relates to early phases of clinical manufacturing and supply.
• Contribute to identifying and interpreting GxP requirements and other appropriate regulations that impact business processes.
• Influence and provide leadership within the broader PR&D organization when internal and external changes may influence the PR&D Quality System (QS) content and architecture.
• Providing phase appropriate guidance on quality topics that are discussed in CM&CC teams or other governance forums.
• Communicating project information/quality issues to Quality Management supporting senior level review of the project (e.g., Spec Committee, DSM, etc.)
• Mentor, coach and/or supervise other quality employees.
• Identify opportunities for and participate in continuous improvement and innovation efforts.
• Stay informed on external regulatory decisions that may impact PR&D and work with Quality and Regulatory to influence external agencies when needed.
• Work externally and cross functionally to understand best practices from a quality standpoint and implement change where needed while creating unique solutions to complex cross functional problems that ultimately support innovation.
• Continually evaluate the state of compliance of the PR&D Quality System and influence senior management to drive improvement by proactively providing a solution.
• Lead/participate teams and projects focused on efforts to improve systems and processes.
• Support both internal and external audits.
• Actively seek internally and externally on expanding knowledge of applicable technology, regulations, and best practices that ultimately drive continuous quality improvements throughout PR&D and drive a quality mindset.

• Bachelor’s degree in a scientific or medical related field or equivalent work experience.
• 10-15 years of experience in development and clinical cGMP manufacturing and supply.

• Demonstrated strong and effective written and verbal communication skills in multicultural and cross functional settings.
• Previous experience in Quality Assurance / Quality Control.
• Proven skill in leading change.
• Strong analytic skills.
• Recognized across functions as a subject matter expert.
• Able to collect data from multiple sources and create a clear narrative.
• Able to prioritise tasks efficiently to handle workloads from a combination of direct staff, indirect reports, and contractors at the PR&D site.
• Ability to build productive relationships and effectively communicate with senior leadership.
• Ability to work in an independent, flexible environment.
• Strong working knowledge of cGMP requirements and GCP regulations.
• Experience in Early Phase CT manufacturing.
• Strong knowledge of Early Phase CT Regulations.
• Experience/knowledge of oligonucleotides and antibody drug conjugate manufacturing, among others.

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $204,600.

Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a…