Position Overview:
The Associate Director β Operational Readiness is a key site leader responsible for developing and managing an integrated project plan to prepare a manufacturing facility for operational readiness. Reporting through site operations, the role works closely with project managers and the Site Lead Team to align workstream deliverables, ensure clear communication across functions (e.g., Ops, TSMS, Engineering, QA, QCL, Maintenance, Logistics, IT), resolve barriers for a safe and timely startup, and leads the siteβs Operational Excellence group (Lean principles and continuous improvement).
Key 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 (dependencies, timelines, resource needs).
- Serve as the main liaison between the GFD project and site teams.
- Lead a cross-functional team to implement the plan, foster collaboration, and build team morale.
- Align scope, goals, and timelines with stakeholders.
- 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.
Basic Qualifications:
- Bachelorβs degree in a relevant discipline (STEM preferred) plus experience in a functional/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 delivery.
- Ability to thrive in dynamic environments and adapt to shifting priorities.
- Skilled in influencing decisions on complex technical challenges.
- Strong organizational/self-management; able to prioritize and adjust workload.
- Effective collaboration across Technical Services, Engineering, Quality, QC, IT, and Operations; integrate workstreams.
- Demonstrated ability to influence peers and business partners.
- Strong interpersonal and team-building skills.
- Track record 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).
Benefits (as stated):
- Anticipated wage: $123,000 - $180,400.
- Company bonus for full-time equivalent employees (based on company/individual performance).
- Eligibility for 401(k), pension, vacation, medical/dental/vision/prescription benefits, flexible benefits, life insurance/death benefits, time off/leave of absence benefits, and well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).