Sr. Director - Quality Control Laboratories

About the role

Lilly is constructing an advanced manufacturing facility for production of API molecules in Huntsville, Alabama. This facility is a significant investment in manufacturing capacity, aimed at producing APIs for current and future products, including new modalities.

Responsibilities

• Build a high-quality organization in support of Quality Laboratory Operations
• Maintain GMP Compliance in all Laboratory Operations
• Deliver the lab of the future vision for LP1 including integrated digital, paperless processes
• Participate on the local area lead teams and Quality Lead Team
• Work closely with Global Quality Laboratories and Global QC Operations to ensure consistent and standardized approaches to laboratory organizational design, business processes, and systems
• Exhibit critical business decision-making, bringing about successful results
• Communicate to and strive for integration with support groups inside and outside the plant
• Coordinate laboratory related business planning and budget management
• Ensure a safe work environment that complies with regulations
• Serve as a conduit for corporate communications as needed
• Oversee Quality and compliance consistency across laboratories
• Coordinate and manage all regulatory and internal inspections
• Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports
• Recruit new talent and develop site capabilities to deliver a high functioning QCL organization
• Ensure administrative and technical capability within the organization

Requirements

• Bachelor’s degree in chemistry, microbiology, engineering, or related discipline
• Minimum of 10 years supporting complex analytical testing (chromatography, bioassay, and analytical characterization)
• 2+ years working in a GMP/cGMP environment
• 5+ years leadership experience
• Expertise in quality and compliance requirements for analytical laboratories
• Experience with regulatory submissions

Qualifications

• Proficiency with computer systems including Microsoft Office products
• Demonstrated technical writing ability
• Demonstrated strong oral and written communication
• Demonstrated interpersonal skills with ability to lead leaders and influence cross-functionally and externally
• Demonstrated ability to maintain a safe work environment

Skills

• Strong analytical operations and quality systems expertise
• Leadership experience in developing and leading large teams
• Ability to influence across the networks and with global organizations

Benefits

The position offers a comprehensive benefit program, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits; life insurance and death benefits; time off and leave of absence benefits; and well-being benefits.

Pay

The anticipated wage for this position is $156,000 - $228,800.

Schedule

Full-time equivalent employees are eligible for a company bonus (depending, in part, on company and individual performance).