Associate Director, Quality Assurance
Eli Lilly and Company
full-time
Posted on:
Location Type: Office
Location: Lebanon • 🇺🇸 United States
Visit company websiteSalary
💰 $123,000 - $180,400 per year
Job Level
Senior
Tech Stack
Vault
About the role
- Provides QA leadership to a team responsible for the startup of a new facility specializing in advanced therapies, e.g. gene therapies (SF9 and HEK platforms), Lipid nanoparticle (LNP, etc) and associated quality systems.
- Once active, support operational excellence initiatives and day-to-day.
- Build out and lifecycle manage new acquisitions and collaboration partners for our advance therapies team, which includes manufacturing oversight, person-in-plant, quality agreements, deviation and change management, and batch release, as needed.
- Maintain a safe work environment; actively support all HSE Site safety goals/initiatives.
- Foster a quality culture that promotes open communication, participation and teamwork.
- Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment.
Requirements
- Bachelor's degree in a science, engineering, pharmaceutical-related field of study or equivalent experience.
- 5+ years in pharmaceutical leadership with specific QA experience, including leading or working effectively with a cross-functional group.
- Strong knowledge of Quality Management Systems, Site Compliance processes, and regulatory requirements (e.g., CFRs, EU, ISO)
- Excellent interpersonal, written and oral communication skills
- Strong technical aptitude and ability to train and mentor others
- Strong self-management and organizational skills, ability to prioritize
- Demonstrated problem-solving and decision-making skills
- Previous regulatory inspection readiness and inspection execution experience
- Regulatory inspection readiness and management experience
- Experience in Advanced Therapies platforms, e.g. Gene Therapy, LNP, etc.
- Previous facility or area start up experience
- Proficiency with industry systems including Kneat, Veeva Vault, SAP, manufacturing execution systems, and Microsoft Office product
Benefits
- 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
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Management SystemsSite Compliance processesregulatory requirementsproblem-solvingdecision-makingAdvanced Therapies platformsGene TherapyLipid nanoparticleregulatory inspection readinessmanufacturing oversight
Soft skills
interpersonal skillswritten communicationoral communicationself-managementorganizational skillsability to prioritizecoachingemployee developmentteamworkopen communication