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 ‚Äúlab of the future‚Äù 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

• Bachelor‚Äôs degree in relevant field (STEM preferred)
• 10+ years of supporting complex analytical testing (mass spec, bioassay, protein characterization)
• 5+ years of supervisory/leadership experience
• 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 (Preferred)