Associate, Quality Assurance, Manufacturing Operations

• Support delivery of the Lilly Medicine Foundry during its design, construction, and startup phase
• Help build a new organization and develop and implement systems and business processes for GMP operations
• Help build the site culture as it grows into a full-scale GMP manufacturing facility
• Provide day-to-day Quality Assurance oversight of GMP manufacturing operations after startup
• Support change management and investigation reviews
• Participate in creating and maintaining a safe work environment
• Foster a collaborative quality culture through open communication, teamwork, and employee participation
• Ensure compliance with applicable laws, regulations, and guidelines supporting GMP activities
• Review GMP documentation, including procedures, deviations, technical reports, and change controls
• Work cross-functionally with plant teams to provide operational support and issue management
• Assist with inspection readiness activities
• Communicate effectively with internal and external stakeholders
• Provide on-call support outside normal working hours when required

• BA/BS degree in Engineering, Science, or another related field
• Minimum of 2 years of technical and/or quality experience in a biotech or pharmaceutical FDA-regulated industry
• Understanding of GMP requirements for early-phase development and manufacturing
• Understanding of quality management systems and their application
• Must be authorized to work full-time in the United States
• Lilly will not sponsor work authorization or visas
• Effective project and time management skills
• Ability to prioritize and handle multiple concurrent tasks
• Problem-solving, verbal reasoning, attention to detail, critical thinking, and analytical competencies
• Strong oral and written communication skills
• Effective organization and self-management skills
• Relevant experience in a cGMP facility preferred
• Relevant industry experience in a high-paced working environment
• Root cause analysis and troubleshooting skills
• Flexibility to adapt to frequent changes and altered priorities
• Ability to identify and prioritize issues and develop and implement solutions
• High learning agility and ability to deal with ambiguity and uncertainty
• Demonstrated attention to detail
• Willingness and ability to provide on-call support outside normal working hours, including nights, weekends, and holidays, when required
• Ability to travel 5%-15%

Demonstrates expertise in GMP operations, quality management systems, and compliance within the biotech or pharmaceutical industry. Capable of fostering a collaborative culture while effectively managing projects and communication across teams.

• GMP Requirements Understanding
• Quality Management Systems
• Root Cause Analysis
• Project Management Skills
• Biotech Industry Experience

• GMP Documentation Review
• Technical Report Analysis
• Change Control Management
• Inspection Readiness
• Problem-Solving Skills

• Effective Communication
• Teamwork
• Attention to Detail
• Time Management
• Flexibility

• FDA-Regulated Industry
• CGMP Facility
• Biotech
• Pharmaceutical
• Quality Assurance