Associate Director - Operational Readiness

Role Summary

The Associate Director – Operational Readiness leads a cross-functional effort to prepare a GMP manufacturing facility for operational readiness. The role develops an integrated startup plan, aligns workstream deliverables, communicates with stakeholders, and embeds Lean principles to enable a safe, timely startup and continuous improvement across the site.

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; 5+ years of experience supporting GMP operations.
• Preferred: Proven experience leading large, cross-functional projects from initiation to successful delivery; ability to thrive in dynamic environments and adapt quickly to shifting priorities; strong organizational and self-management skills; effective collaboration across diverse functions; demonstrated ability to influence peers and business partners; proficiency in continuous improvement methodologies (Lean, Six Sigma); familiarity with documentation, deviation, and change management systems (e.g., TrackWise, Veeva, QualityDocs, Kneat).