Associate Director - QA - Lebanon API

Lilly • Lebanon, IN

4d • $123,000 - $180,400 • Onsite

About The Position

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 responsibility to oversee the team's performance, resolution of quality issues and compliance.

Requirements

• BS in Engineering or science related field
• 5+ years in CGMP manufacturing
• Prior work with cGMPs or external regulations
• Strong knowledge of Quality Management Systems and applicable regulatory requirements

Nice To Haves

• 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
• Previous experience with root cause investigations

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 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.

Benefits

• company bonus
• company-sponsored 401(k)
• pension
• vacation benefits
• medical benefits
• dental benefits
• vision benefits
• prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance
• death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Director