Global Pharma Project Leader - GMP, C&Q & Commissioning

AbbVie Inc.; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

AbbVie Inc. in the United States seeks an experienced Project Manager for global capital projects in pharma. You will lead cross-functional teams across design, procurement, and commissioning to deliver on schedule and budget.

The role requires deep knowledge of FDA/GMP, C&Q, and risk-based approaches, with travel to sites within AbbVie network. Strong leadership and communication are essential.

Qualifications

• Bachelor’s degree in engineering, Science, Life Sciences, or related field.
• 10+ years of experience in project management/execution, commissioning & qualification within pharma/biotech or related regulated industry.
• Strong knowledge of FDA, GMP, ICH Q8/Q9/Q10 regulations and industry standards.
• High technical knowledge in Biopharmaceutical Drug Substance Manufacturing and Aseptic Fill Finish is a plus.
• Experience coordinating with Architecture, CM teams and key trades to maintain schedules.

Responsibilities

• Provide leadership for capital investment projects across the AbbVie network, including funding definition, engineering, design, procurement support, scheduling, and commissioning.
• Lead stakeholders and SMEs through design reviews for facility, utility and equipment.
• Deliver capital plan LBE per finance and project accounting schedules.
• Provide weekly/monthly project status reports and gate reviews.
• Coordinate and lead shutdown-related activities with all stakeholders.
• Lead final walkdowns of punch lists and engineering turnover packages.
• Adhere to global engineering standards for facilities, utilities, and equipment.
• Manage equipment suppliers during procurement, design, build and C&Q phases.
• Onboard SMEs to support project-specific needs.
• Lead, motivate and supervise a high-skilled project team with technical guidance.
• Support commissioning and qualification strategies aligning with FDA/GMP policies.
• Plan and coordinate C&Q activities using a risk-based RBV approach.
• Incorporate deliverables into scheduling tools and monitor earned value metrics.
• Coordinate with engineering, quality, operations, maintenance and external vendors to ensure on-time, on-budget delivery.
• Drive risk assessment consistency with a risk-based approach throughout the lifecycle.
• Review and approve documentation ensuring accuracy of final deliverables.
• Support inspections and provide SME input on qualification activities.
• Stay updated with regulatory changes and industry best practices.
• Collaborate with Global Engineering, Site Operations, PDS&T and Quality to drive knowledge transfer.

Skills

Project management

Regulatory knowledge

Cross-functional leadership

Communication skills

Risk assessment

Education

Bachelor’s degree in engineering, Science, Life Sciences, or related field

Tools

DCS/CSA knowledge

Job description

AbbVie Inc. in the United States seeks an experienced Project Manager for global capital projects in pharma. You will lead cross-functional teams across design, procurement, and commissioning to deliver on schedule and budget.

The role requires deep knowledge of FDA/GMP, C&Q, and risk-based approaches, with travel to sites within AbbVie network. Strong leadership and communication are essential.