Sr. Director - Quality Control Laboratories

About the role

The Sr. Director – QC Laboratories will provide administrative leadership for the quality laboratories and ensure appropriate capabilities and business processes are developed at the site. The role will define and lead the organization that will support the quality control and analytical laboratories in support of the site and Lilly’s growing pipeline.

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
• Works 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 bringing about successful results
• Communicate to and strive for integration with support groups inside and outside the plant
• Cook up laboratory related business planning and budget management
• Ensure safe work environment that complies with regulations
• Serve as a conduit for corporate communications as needed
• Quality and compliance consistency across laboratories
• Coordinate and manage all regulatory and internal inspections
• Personnel Development
• 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

Basic 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

Additional Skills/Preferences

• 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