Associate Director - Operational Readiness

Role Summary

Associate Director – Operational Readiness at Lilly, a leadership role in preparing a greenfield API manufacturing facility for GMP operations. Leads the integrated startup plan, aligns workstreams, and drives lean, continuous improvement culture to enable a safe, timely startup.

Responsibilities

• Identify essential pre-manufacturing elements for facility readiness with input from cross-functional stakeholders.
• Collaborate with the GFD project team and site functions to develop an integrated startup plan, addressing dependencies, timelines, and resource needs.
• Serve as the main liaison between the GFD project and site teams to ensure clear communication and aligned priorities.
• Lead a cross-functional team to implement the plan, foster collaboration, and build team morale.
• Align scope, goals, and timelines with stakeholders to meet project objectives.
• Drive timely decision-making under tight deadlines.
• Manage communications and relationships with internal and external stakeholders.
• Proactively resolve issues and implement corrective actions.
• Forecast and manage resource needs to avoid project delays.
• Report key metrics to site and network governance forums.
• Apply lean management practices to streamline meetings, communication, and escalation.
• Build a culture of operational excellence and embed Lean principles into site governance.

Qualifications

• Required: Bachelor's degree in a relevant discipline (STEM degree preferred) and experience in a functional or operational leadership role within the pharmaceutical industry.
• Required: 5+ years of experience supporting GMP operations.
• Preferred: Proven experience leading large, cross-functional projects from initiation to successful delivery.
• Preferred: Ability to thrive in dynamic environments and adapt quickly to shifting priorities.
• Preferred: Skilled in influencing decisions on complex technical challenges.
• Preferred: Strong organizational and self-management skills; ability to prioritize and adjust workload effectively.
• Preferred: Effective collaboration across diverse functions (e.g., Technical Services, Engineering, Quality, QC, IT, Operations) with ability to integrate workstreams.
• Preferred: Demonstrated ability to influence peers and business partners.
• Preferred: Strong interpersonal and team-building skills; fosters effective collaboration among diverse styles.
• Preferred: Track record of delivering high-performance projects on time and within budget.
• Preferred: Proficient in continuous improvement methodologies (Lean, Six Sigma, etc.).
• Preferred: Familiarity with documentation, deviation, and change management systems (e.g., TrackWise, Veeva, QualityDocs, Kneat).

Skills

• Lean principles and continuous improvement
• Project management and cross-functional leadership
• Stakeholder management and communication
• Resource planning and risk management
• Change management and issue resolution
• Operational readiness for GMP manufacturing

Education

• Bachelor's degree in a relevant discipline (STEM preferred)