Full Job Description
Lilly is currently constructing an advanced manufacturing facility for production of Active Pharmaceutical Ingredient (API) molecules located in Lebanon, Indiana, USA. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations
Job Position Overview:
The Quality Assurance Associate Director provides quality oversight to the API manufacturing processes. The Associate Director is responsible for managing the development of direct reports and prioritizing work appropriately to implement LP1 and QA objectives. This position will have a primary focus on the oversight of operational readiness and initiation of production within the synthetic peptide facilities. The role has responsiblity to oversee the team's performance, resolution of quality issues and compliance.
Responsibilities:
• Provide direct quality oversight to LP1 manufacturing and assist others in interpretation of regulatory and corporate requirements
• Provide quality guidance, technical support and recommendations to equipment and process issues and continuous improvement initiatives. Lead resolution of quality issues.
• Work with cross functional teams to implement QA objectives
• Prepare for and participate in internal and external regulatory inspections. Lead the broader QA team in maintaining and improving site quality sysetms, ensuring alignment with global quality standards and external regulations.
• Guide and coach QA manufacturing staff, including performance management and career development.
• Coach and mentor QA manufacturing representatives in aspects of QA support including process understanding, problem solving, project management and deviation investigation/resolution.
Basic Requirements:
• BS in Engineering or science related field
• 5+ years in CGMP manufacturing
Additional Skills/Preferences:
• Previous leadership experience in pharmaceutical industry
• Prior experience with synthetic peptide manufacturing, in QA, TS/MS, QC or Engineering
• Demonstrated problem solving and decision making skills
• Demonstrated strong written and verbal communication skills, with a strong attention to detail
• Strong technical aptitude, analytical thinking skills and ability to train and mentor others
• Prior work with cGMPs or external regulations
• Previous experience with root cause investigations
• Strong knowledge of Quality Management Systems and applicable regulatory requirements
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$123,000 - $180,400
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.
