Associate Director Quality Systems
Eli Lilly and Company
August 11, 2026
On-site
Richmond, VA
Operations
Associate Director Quality Systems
Key Responsibilities
- GMP Compliance: Escalate critical quality issues per site Notification to Management procedure; review and approve quality documents (e.g., Vendor Management, Service Providers, Document Control); review and approve deviations and quality-related documents (e.g., QA e-systems, QA procedures, change controls).
- Quality Systems And Customer Focus: Implement improvements within quality systems; supervise Vendor management reps, QA E-Systems rep, and Document Control; collaborate with internal teams and customers to improve quality systems; resolve quality issues pertaining to E-Systems and vendor management.
- Technical Excellence: Provide tools/resources for QA systems and compliance unit; provide technical leadership/advice for key quality issues; develop and maintain report training, performance management plans, reviews, career plans; support assignments/workload management.
- Corporate/Site Strategy And Mission: Support expense/capital/headcount/project business planning aligned to GMP and compliance requirements.
Minimum Qualifications
- BS in Pharmacy, Science, Engineering, or related discipline.
- 8+ years quality assurance experience in relevant manufacturing.
- 4+ years leadership experience with direct reports.
Additional Skills/Preferences
- Strong knowledge of cGMP, FDA, EMA, Data Integrity, Quality Risk Management, and biopharmaceutical regulatory requirements.
- Quality Systems experience (required).
- Excellent problem-solving/analytical skills; detail-oriented; strong communication/teamwork; proactive continuous improvement.
- Plus: TrackWise; automation systems (e.g., Kneat, DCS, DeltaV).
Additional Requirements/Information
- Travel: 0–20% initially; intra-site travel required.
- Ability to work with internal/external stakeholders and field incoming requests timely.
Benefits (as stated)
- Eligible for company bonus; 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.
Key Responsibilities
- GMP Compliance: Escalate critical quality issues per site Notification to Management procedure; review and approve quality documents (e.g., Vendor Management, Service Providers, Document Control); review and approve deviations and quality-related documents (e.g., QA e-systems, QA procedures, change controls).
- Quality Systems And Customer Focus: Implement improvements within quality systems; supervise Vendor management reps, QA E-Systems rep, and Document Control; collaborate with internal teams and customers to improve quality systems; resolve quality issues pertaining to E-Systems and vendor management.
- Technical Excellence: Provide tools/resources for QA systems and compliance unit; provide technical leadership/advice for key quality issues; develop and maintain report training, performance management plans, reviews, career plans; support assignments/workload management.
- Corporate/Site Strategy And Mission: Support expense/capital/headcount/project business planning aligned to GMP and compliance requirements.
Minimum Qualifications
- BS in Pharmacy, Science, Engineering, or related discipline.
- 8+ years quality assurance experience in relevant manufacturing.
- 4+ years leadership experience with direct reports.
Additional Skills/Preferences
- Strong knowledge of cGMP, FDA, EMA, Data Integrity, Quality Risk Management, and biopharmaceutical regulatory requirements.
- Quality Systems experience (required).
- Excellent problem-solving/analytical skills; detail-oriented; strong communication/teamwork; proactive continuous improvement.
- Plus: TrackWise; automation systems (e.g., Kneat, DCS, DeltaV).
Additional Requirements/Information
- Travel: 0–20% initially; intra-site travel required.
- Ability to work with internal/external stakeholders and field incoming requests timely.
Benefits (as stated)
- Eligible for company bonus; 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.