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.

Key Responsibilities

• 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.
• Business Management Role: Developer of measures; Improvement promoter; Technical leader / guide; Decision maker; Event manager; Daily contact person / co-ordinator
• People Management Role: Performance manager / improver / coach; Role model; Policy administrator / Decision maker; Team builder / motivator; Main link in the communications chain.
• Site Management Role: Member of site management with shared responsibility for the site meeting its targets; Focus on 1–2-year business planning and resource allocation.

Minimum Qualifications

• 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.

Additional Skills/Preferences

• Strong knowledge of cGMP, FDA, EMA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
• Quality Systems experience is a must.
• 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 mind-set.
• Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., Kneat, DCS, DeltaV) is a plus.

Additional Requirements

• Travel: 0-20% in the beginning.
• Intra-Site travel required.
• The individual must work with a wide variety of people both internal and external to the Quality Unit.
• Ability to field incoming requests in a timely, appropriate manner.
• Processes are continually being improved and a willingness to implement change is important.

Pay & Benefits

• Anticipated wage: $123,000 - $180,400
• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• Comprehensive benefit program including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).