Associate Director - Quality Control Lab Project Lead

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$111,000 - $162,800

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Associate Director - Quality Control Lab Project Lead is responsible for the new site QC projects and startup phase of the QC labs. This role is responsible for leading the detailed lab design working in partnership with the Global Facilities Delivery (GFD) organization and quality leadership to support the site readiness activities including design aspects, E-systems, procedures, processes, and organizational elements necessary to support GMP lab testing in support of manufacturing operations. 

Key Objectives/Deliverables: 

The Associate Director - Quality Control Lab Project Lead is responsible to:

• Act as GMP Lab Design Lead, working with Global Facility Delivery, Lilly project staff, Lilly Quality Control leadership and selected design firm to complete the detailed design of the lab area including the purchase and qualification of all laboratory analytical instrumentation and equipment employing QbD and Lean Lab principles.
• Interact with the other global, project and functional areas to coordinate startup activities to support the overall project and site schedule.
• Serve as technical resource and review and approve technical documents.
• Work with the Lab Robotics and Lab IT areas for integrating future technology and systems into the delivery plan for startup or future use
• Work with the Global Quality Leader, Sr. Director Quality Control Operational Excellence, and Site/Network QC leadership to support the development of the vision and strategy for site laboratory operations for all testing labs.
• Work with quality leadership in support of initial recruiting, build capability, for a diverse leadership and lab staff to support the qualification and startup of the Lab operations.
• Ensure all aspects of safety are incorporated into the design and maintaining a safe work environment, including supporting all HSE Corporate and Site Goals.
• Establish a lab operation compliant with Lilly Global Quality Standards and regulatory requirements, including partnering with laboratory management and staff to establish lab practices, procedures, test method transfers, etc.
• Establish connections with the Global Quality Lab Network and actively working with the network to support global initiatives.
• Establish Lean Lab and efficient lab operations with a process for monitoring lab performance and continuously improving the operations.
• Ensuring appropriate planning for lab materials, chemicals, supplies, and services to support lab operations.
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
• Network with other areas to understand best practices, share knowledge, participate in tactical and strategic business planning, and to ensure customer needs are met.

Education:

• BS or MS in Chemistry/Biology/Microbiology/Engineering or related science.

Experience:

• 10+ years GMP lab experience including analytical testing and method transfer.

Additional Skills/Preferences includes:

• Deep understanding of compliance requirements and regulatory expectations.
• Excellent written and oral communication skills.