Sr. Project Manager

About the role

We are seeking a highly experienced Sr. Project Manager to lead the planning, implementation, and execution of an integrated Verification and Commissioning & Qualification (C&Q) Program for large-scale GMP-regulated capital projects.

Responsibilities

• Lead the development and execution of an integrated Verification and C&Q Program across the full project lifecycle, from design through operational handover.
• Establish and implement project-specific verification strategies aligned with ASTM E2500 principles and industry best practices.
• Manage overall C&Q scope, budget, schedule, resource planning, and project risks.
• Serve as the primary point of contact for all C&Q-related matters with project leadership and key stakeholders.
• Develop detailed C&Q execution plans, staffing strategies, milestone schedules, and performance metrics.
• Ensure C&Q activities are integrated with engineering, construction, automation, validation, quality, and operational readiness plans.
• Lead, mentor, and develop multidisciplinary C&Q teams supporting project execution.
• Manage day-to-day team activities, task assignments, priorities, and performance.
• Facilitate daily, weekly, and monthly project meetings to track progress and resolve issues.
• Provide technical guidance and oversight to ensure consistent application of verification methodologies and C&Q best practices.
• Train project teams, contractors, and service providers on verification-based delivery methodologies and project-specific C&Q requirements.
• Oversee implementation of the project verification strategy, ensuring verification activities are executed by the appropriate functional teams throughout the project lifecycle.
• Direct development, review, approval, and execution of verification plans, test cases, commissioning protocols, and qualification documentation.
• Ensure requirements traceability from design through testing and final system acceptance.
• Support risk-based qualification approaches and critical aspect verification in accordance with ASTM E2500 principles.
• Ensure timely completion of turnover packages and system release activities.
• Collaborate closely with Engineering, Construction, Automation, Quality Assurance, Validation, Manufacturing, Facilities, and Project Controls teams.
• Drive alignment between project objectives, design intent, compliance requirements, and operational expectations.
• Facilitate resolution of technical, compliance, and execution challenges impacting C&Q deliverables.
• Influence project decisions and priorities to support successful delivery of verification and qualification objectives.
• Monitor and report project progress, resource utilization, budget performance, and key C&Q metrics.
• Identify and mitigate schedule, quality, compliance, and execution risks.
• Escalate critical issues impacting project delivery and drive timely resolution.
• Provide regular status updates and executive-level communications to project leadership and stakeholders.
• Promote a strong safety culture and ensure compliance with all site and project safety requirements.
• Ensure implementation of safe work practices, permitting requirements, and field execution procedures.
• Maintain compliance with GMP regulations, quality systems, and applicable industry standards throughout project execution.
• Support audits, inspections, and regulatory interactions as required.

Qualifications and Requirements

• Education: Bachelor's Degree in Engineering, Life Sciences, or a related technical discipline. Advanced degree, PMP certification, or equivalent professional certification preferred.
• Experience: 10–15+ years of experience supporting GMP-regulated pharmaceutical, biotechnology, cell and gene therapy, or medical device projects. Demonstrated experience leading Commissioning, Qualification, Verification, or Validation programs on large capital projects. Experience delivering at least one major greenfield or brownfield GMP facility from early design through startup, qualification, turnover, and project closeout. Strong knowledge and application of ASTM E2500 verification methodology and risk-based qualification approaches. Experience managing FAT, SAT, commissioning, qualification, verification testing, and system turnover activities. Working knowledge of facility, utility, process, automation, and manufacturing systems commonly deployed within GMP environments. Experience managing budgets, resource plans, schedules, and contract service providers. Familiarity with GMP documentation practices, quality systems, change controls, deviations, CAPAs, and validation lifecycle requirements. Experience with electronic validation systems and digital quality platforms, including Kneat, ValGenesis, or similar platforms, is preferred.
• Knowledge, Skills, and Abilities: Strong understanding of GMP regulations, commissioning, qualification, validation, and verification practices. Deep knowledge of ASTM E2500 and lifecycle-based validation methodologies. Demonstrated leadership experience managing large, cross-functional project teams. Excellent organizational, planning, and project management skills. Strong communication skills with the ability to engage effectively with technical and non-technical stakeholders. Proven ability to influence decision-making and drive alignment across multiple functional groups. Strong analytical, problem-solving, and risk-management capabilities. Ability to manage multiple priorities in fast-paced project environments. Commitment to quality, compliance, safety, and continuous improvement.