Sr. Director - API Manufacturing Quality Control

Role Summary

The Sr. Director – QC provides strategic and administrative leadership for the quality control and analytical sciences laboratories at a new Lilly API site. This role ensures the development of essential capabilities and business processes to support site operations and Lilly’s expanding pipeline.

Responsibilities

• Build and lead a high-performing Quality Laboratory Operations team
• Ensure GMP compliance across all lab activities
• Deliver the “lab of the future” vision with integrated digital, paperless processes
• Collaborate with local and global quality teams to standardize lab design, processes, and systems
• Participate in site and quality leadership teams
• Drive strategic decisions and successful business outcomes
• Coordinate lab-related planning and budget management
• Promote cross-functional integration and communication
• Maintain a safe, compliant work environment
• Serve as a liaison for corporate communications
• Ensure consistent quality and compliance across laboratories
• Manage regulatory and internal inspections
• Lead HR planning, performance management, and talent development
• Recruit and build site capabilities for a high-functioning QC lab organization
• Ensure strong administrative and technical leadership within the team

Qualifications

• Required: Bachelor’s degree in relevant field (STEM preferred)
• Required: 10+ years of supporting complex analytical testing (mass spec, bioassay, protein characterization)
• Required: 5+ years of supervisory/leadership experience
• Preferred: Knowledge of QC operations, new product introduction, and process development
• Preferred: Expertise in analytical lab quality and compliance requirements
• Preferred: Experience with regulatory submissions
• Preferred: Proficient in Microsoft Office and other computer systems
• Preferred: Strong technical writing and communication skills
• Preferred: Effective interpersonal skills with ability to lead leaders and influence cross-functionally
• Preferred: Commitment to maintaining a safe work environment

Education

• Bachelor’s degree in relevant field (STEM preferred)

Skills

• Analytical laboratory operations
• Quality systems and GMP/compliance
• Technical writing and documentation
• Cross-functional leadership
• Communication and interpersonal skills
• Digital/process modernization (paperless environments)