Associate Director Quality Systems

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly is building a next-generation biotech drug substance manufacturing facility in Richmond, VA-our most technically advanced site to date. This greenfield facility will feature cutting-edge manufacturing technologies and advanced data platforms designed to drive improvements in safety, quality, and productivity. This is a rare opportunity to shape an organization, a facility, and a culture from the ground up.

The Associate Director Quality Systems plays a critical role in providing Quality leadership, direction, and governance for Quality systems and compliance, within our manufacturing facility. You will work closely with cross-functional teams to provide quality system guidance.

• Responsible for the escalation of critical quality issues as appropriate to line management and off-site Quality Assurance management consistent with the site procedure on Notification to Management
• Responsible for review and approval of specific quality documents consistent with procedure requirements; including, but not limited to, documents associated with Vendor Management, Service Providers, Quality Systems such as Document Control
• Responsible for review and approval of specific quality documents consistent with procedure requirements; including, but not limited to, deviations associated with QA e-systems, Quality Assurance procedures, change controls, etc.

• Responsible for implementing improvements within quality systems
• Specific responsibility for supervision of Vendor management reps, QA E-Systems rep and Document Control
• Involved with Vendor management reps, Doc. Control Management, QA E-Systems rep, QA Assistants, Site Self-Assessment and customers in improving the quality systems at the site.
• Responsible for business processes or resolution of quality issues pertaining to E-Systems, vendor management.

• Provides the tools and resources to allow the QA systems and compliance unit to carry out their responsibilities.
• Provides technical leadership and advice for key quality issues
• Works with individual reports to develop & maintain their training, performance management plans, reviews & career plans; provides consensus feedback and helps manage assignments & workloads

• Supports the organisation through expense, capital, headcount, and project business planning and aligning with various sites and corporate business plans in respect of GMP and compliance requirements and standards.
• Have responsibilities consistent with the responsibilities, summarised below:

• Developer of measures.
• Improvement promoter.
• Technical leader / guide
• Decision maker
• Event manager
• Daily contact person / co-ordinator

• Performance manager / improver / coach
• Role model
• Policy administrator / Decision maker
• Team builder / motivator
• Main link in the communications chain.

• Member of site management with shared responsibility for the site meeting its targets.
• Focus on 1-2-year business planning and resource allocation.

• BS in Pharmacy, Science, Engineering or related discipline.
• Minimum of 8 years of experience in quality assurance within a relevant manufacturing environment.
• Minimum of 4 years leadership experience with direct reports.

• Strong knowledge of cGMP, FDA, EMA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
• Quality Systems experience is a must.
• Exc…