Associate Director Quality Systems

About the role

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.

Responsibilities

• GMP Compliance:
  • Escalate critical quality issues to line management and off-site Quality Assurance management as per site procedures.
  • Review and approve specific quality documents, including those associated with Vendor Management, Service Providers, Quality Systems such as Document Control, deviations associated with QA e-systems, Quality Assurance procedures, and change controls.
• Quality Systems and Customer Focus:
  • Implement improvements within quality systems.
  • Supervise Vendor management representatives, QA E-Systems representatives, and Document Control.
  • Collaborate with Vendor management reps, Document Control Management, QA E-Systems reps, QA Assistants, Site Self-Assessment, and customers to improve quality systems at the site.
  • Resolve quality issues pertaining to E-Systems and vendor management.
• Technical Excellence:
  • Provide tools and resources to enable the QA systems and compliance unit to carry out their responsibilities.
  • Offer technical leadership and advice for key quality issues.
  • Develop and maintain training, performance management plans, reviews, and career plans for individual reports; provide consensus feedback and manage assignments and workloads.
• Corporate/Site Strategy and Mission:
  • Support the organization through expense, capital, headcount, and project business planning, aligning with various sites and corporate business plans regarding GMP and compliance requirements.
  • Serve in a business management role as a developer of measures, improvement promoter, technical leader, decision-maker, event manager, and daily contact person/coordinator.
  • Act as a people manager by improving performance, coaching, role modeling, administering policies, making decisions, building and motivating teams, and serving as the main communications link.
  • Participate in site management with shared responsibility for meeting site targets, focusing on 1–2-year business planning and resource allocation.

Requirements

• 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 of leadership experience with direct reports.

Skills

• Strong knowledge of cGMP, FDA, EMA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements.
• Quality Systems experience is essential.
• Excellent problem-solving and analytical skills.
• Detail-oriented with a strong commitment to maintaining high-quality standards.
• Effective communication and teamwork skills.
• Demonstrated initiative—able to work proactively without direct supervision and with a continuous improvement mindset.
• Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., Kneat, DCS, DeltaV) is a plus.

Additional Information

• Travel: 0-20% initially, with intra-site travel required.
• Ability to work with a wide variety of internal and external stakeholders.
• Must field incoming requests in a timely and appropriate manner.
• Willingness to implement change as processes continually improve.

Benefits

• Comprehensive benefit program including:
  • Company-sponsored 401(k) and pension plans.
  • Vacation benefits.
  • 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).
• Company bonus depending on company and individual performance.

Pay

The anticipated wage for this position is $123,000 - $180,400.