Associate Director - QA - Lebanon API

About the role

The Quality Assurance Associate Director provides quality oversight to the API manufacturing processes. The role oversees the development of direct reports, prioritizes work, and implements LP1 and QA objectives. The primary focus is on the oversight of operational readiness and initiation of production within the synthetic peptide facilities.

Responsibilities

• Provide direct quality oversight to LP1 manufacturing and assist others in interpreting regulatory and corporate requirements
• Provide quality guidance, technical support, and recommendations for equipment and process issues, and 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 systems, 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

Requirements

• Bachelor's degree in Engineering or a science-related field
• 5+ years in CGMP manufacturing

Qualifications

• 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

Skills

• 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

Benefits

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).

Pay

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.

Schedule

This is a full-time position.