Associate Director - Operational Readiness

Role Summary

The Associate Director – Operational Readiness is a key site leader responsible for developing and managing an integrated project plan to prepare the manufacturing facility for operational readiness. This role leads the site’s Operational Excellence group, establishing Lean principles and a continuous improvement framework, to ensure a safe, timely, and successful startup of GMP manufacturing operations.

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

• 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

Additional Preferences

• Proven experience leading large, cross-functional projects from initiation to successful delivery
• Ability to thrive in dynamic environments and adapt quickly to shifting priorities
• Skilled in influencing decisions on complex technical challenges
• Strong organizational and self-management skills; able to prioritize and adjust workload effectively
• Effective collaboration across diverse functions (e.g., Technical Services, Engineering, Quality, QC, IT, Operations) with ability to integrate workstreams
• Demonstrated ability to influence peers and business partners
• Strong interpersonal and team-building skills; fosters effective collaboration among diverse styles
• Track record of delivering high-performance projects on time and within budget
• Proficient in continuous improvement methodologies (Lean, Six Sigma, etc.)
• Familiarity with documentation, deviation, and change management systems (e.g., TrackWise, Veeva, QualityDocs, Kneat)