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. 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.

Responsibilities

You will work closely with cross-functional teams to Provide Quality system guidance. Key responsibilities include:

• GMP Compliance: 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
• 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
• Quality Systems And Customer Focus: Responsible for implementing improvements within quality systems, supervision of Vendor management reps, QA E-Systems rep and Document Control
• Technical Excellence: Provides the tools and resources to allow the QA systems and compliance unit to carry out their responsibilities, technical leadership and advice for key quality issues
• Corporate/Site Strategy And Mission: 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

Qualifications

Minimum qualifications include:

• 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

Skills

Additional skills and preferences include:

• 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

Benefits

Lilly offers a comprehensive benefit program to eligible employees, 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
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Pay

The anticipated wage for this position is $123,000 - $180,400. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Schedule

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.