Director, Project Management IM, Fill Finish, Device Assembly & Packaging

Role Summary

Director, Project Management IM, Fill Finish, Device Assembly & Packaging. Location: Wilson, North Carolina. Lead high-visibility capital projects across Innovative Medicine, from concept through facility startup, with a focus on Fill Finish facilities and regulatory readiness. Ensure safety, scope, schedule, cost, and quality, and align stakeholders to enable product launches and operational readiness. Build and mentor multidisciplinary teams to deliver compliant, best-in-class facilities.

Responsibilities

• Provide portfolio-level leadership, integrating strategy, execution, and governance across multiple large capital projects.
• Own project delivery KPIs and drive proactive decision-making via transparent reporting.
• Lead risk, change, and issue management with clear escalation paths and recovery planning.
• Build and mentor high-performing teams; develop future leaders and an inclusive, safety-first culture.
• Ensure compliance with J&J standards and regulatory requirements throughout design, construction, C&Q, and startup.
• Lead full lifecycle delivery of the Fill Finish facility—from detailed design through validation—ensuring aseptic manufacturing readiness and regulatory compliance.
• Own critical path Long-Lead Equipment (LLE) strategy for Filling Lines, Inspection Systems, and Packaging; drive tendering, award, FAT/SAT, installation, and qualification.
• Coordinate interfaces to GMP Operational Readiness (OR), including procedures, training, material flows, EM, and readiness gates.
• Partner with Tech Transfer and Process Qualification teams to align equipment capability with process needs (PPQ strategy, sampling, data integrity).
• Optimize layout for segregation, unidirectional flow, and human/material/airflow build to support sterility assurance and efficiency.

Qualifications

• Required: Bachelor's degree in Engineering, Architecture, or Construction Management (advanced degree preferred).
• Required: 10+ years leading large, sophisticated capital projects in regulated environments (FDA/EMA or similar).
• Required: Proven ability to lead cross-functional teams and external partners to deliver business outcomes.
• Required: Financial acumen (business cases, forecasts, cost control) and proficiency in schedule/risk management.
• Required: Fluency in English.
• Preferred: Track record leading aseptic DP (fill finish) projects with LLE on the schedule critical path.
• Preferred: Vendor management experience across isolators, fillers, optical inspection, device assembly and secondary packaging.
• Preferred: Demonstrated collaboration with Manufacturing, Quality, and MSAT/TT for PPQ and launch.

Skills

• Strategic Systems Thinking & Decision Quality
• Influence Without Authority & Executive Communication
• Technical Depth in Design/Construction/C&Q for regulated facilities
• Risk-Based Planning & Schedule/Cost Discipline
• Supplier & Contracting Strategy; Partner Management
• Talent Development & Inclusive Leadership
• Agile Decision Making
• Analytics Insights
• Budget Management
• Business Savvy
• Developing Others
• Give Feedback
• Inclusive Leadership
• Leadership
• Organizational Project Management
• Performance Measurement
• Program Management
• Project Management Methodology (PMM)
• Project Management Office (PMO)
• Project Management Tools
• Project Reporting
• Regulatory Compliance
• Statement of Work (SOW)

Education

• Bachelor’s degree in Engineering, Architecture, or Construction Management (advanced degree preferred).

Additional Requirements

• Travel: 25–50% travel (domestic and international) as required.