Associate Director-Quality Control

Eli Lilly • Concord, NH

224d • $118,500 - $173,800

About The Position

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 lifechanging 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, will serve as site-based laboratory leadership supporting activities to include organizational design, staffing, procedures, and processes necessary to provide GMP lab testing in support of manufacturing operations.

Requirements

• Bachelor of Science in Chemistry/Biology/Microbiology or related science.
• Previous pharmaceutical leadership experience including leading or working effectively with a cross functional group.
• 5+ years GMP lab experience including analytical testing and method transfer.

Nice To Haves

• Deep understanding of compliance requirements and regulatory expectations.
• Excellent written and oral communication skills.
• Previous LEAN experience.
• Experience operating or implementing Lab IT systems including LIMS and Automated Lab Execution systems.
• Strong technical aptitude and ability to train and mentor others.
• Project management experience.
• Demonstrated problem-solving and decision-making capability.
• Demonstrated technical writing skills.
• Proven cross-functional leadership.
• Proven people leadership skills.

Responsibilities

• Lead the Analytical Chemistry and Device testing teams, supporting continued startup and routine operation of the Quality Control Laboratories.
• Serve as technical resource to review and approve technical documents.
• Work with the Lab Robotics and Lab IT areas for integrating future technology and systems, including LIMS.
• Responsible for the strategy with focus on the site laboratory operations for the chemical and device testing labs.
• Support recruiting and build capability for a diverse leadership and lab staff.
• Maintain overall responsibility for establishing a QC Lab Operation.
• Ensure all aspects of safety are incorporated into lab processes and maintain a safe work environment.
• Maintain a lab operation compliant with Lilly Global Quality Standards and regulatory requirements.
• Establish connections with the Global Quality Lab Network and actively work with the network to support global initiatives.
• Establish Lean Lab and efficient lab operations with a process for monitoring lab performance.
• Ensure setup of all lab materials, chemicals, supplies, and services to support lab operation.
• Foster a strong quality culture including maintaining open communications and promoting teamwork.
• Supervise, coach, and aid in employee development and performance management.
• Network with other areas to understand best practices and ensure customer needs are met.
• Set QC Lab human resource and business plan goals.
• Define and execute inspection readiness activities.
• Interact with regulatory agencies during inspections regarding cGMP issues.
• Facilitate assessment of assay variability contribution to total process variability.
• Ensure data integrity by design.

Benefits

• 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.
• Wellbeing benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree