Pharmaceutical Project Manager

Summary

This role is the day-to-day project lead for validated environment and laboratory construction projects (e.g., clean rooms, biosafety cabinets, containment suites, biocontainment labs, and related utilities) across a campus.

The Project Manager will report to the Project Executive and partner with Engineering, QA/Validation, Delivery, Sponsors, and regional leadership to deliver projects within a validated-state framework, focusing on operational excellence, compliance, and both tactical and financial performance.

• Plan, execute, monitor, and close validated environment projects across multiple sites, ensuring IQ/OQ/PQ, equipment qualification, data integrity, and regulatory expectations are met.
• Serve as the on‑site/day‑to‑day project lead, coordinating Owners, Architects, Engineers, QA/Validation, Contractors, and Vendors to achieve project objectives within validated‑state constraints.
• Collaborate with the Project Executive to define and maintain project scope, schedule, and budget baselines; monitor progress and report deviations. Drive project schedule with a sense of urgency while not compromising quality.
• Develop and implement validation strategies and documentation (validation plans, commissioning/qualification activities, and related records) aligned with corporate validation policy.
• Identify, assess, and mitigate project‑level risks that could impact deliverables, schedules, budgets, data integrity, or compliance; escalate as needed with proposed remedies.
• Track and report project performance to the Project Executive, including schedule status, budget, risk, QA/validation progress, and regulatory readiness.
• Manage and appropriately change orders, project delays, procurement, and contract administration for assigned projects; ensure alignment with validated baselines and contract requirements. Update all logs at least weekly. Manage all documentation as per standards in Solution Navigator.
• Ensure robust documentation controls that meet contract, QA, and regulatory standards (validation protocols, IQ/OQ/PQ records, SOP alignment, QA approvals) and support regulatory inspections.
• Seek opportunities to improve validation workflows, data integrity practices, and delivery quality to enhance client satisfaction.
• Maintain relationships with sponsors and stakeholders; act as a trusted advisor on validated‑environment delivery and compliance at the project level.
• Manage vendor and subcontractor performance for assigned projects, selecting qualified partners and ensuring alignment with timelines and objectives.
• Manage project finances at the assignment level, including budgeting, forecasting, progress billings, and payables, ensuring alignment with project baselines.
• Prepare the project team for regulatory inspections and audits through thorough documentation and traceability.
• Foster a safe, compliant, and collaborative project environment; provide guidance to junior team members as needed.

• Bachelor’s degree in construction, civil, mechanical, electrical engineering, construction management, business management, architecture, or a related field.
• 5–10 years of direct project management experience on large capital projects, including regulated or validated settings (typical project sizes in the $5–$20M range; portfolio responsibility not required).
• Demonstrated success delivering complex, multi‑site projects in validated environments (GMP/GLP/ISO 17025) within labs, biopharma, pharmaceutical manufacturing, medical devices, healthcare, or related sectors.
• Understanding of contract language, project accounting, and basic portfolio management as they apply to validated environments.
• Strong executive communication skills; ability to present to senior leadership and diverse stakeholder groups; capable of influencing across functional boundaries.
• Ability to lead and coordinate cross‑functional teams (Owners, Architects, Engineers, QA/Validation, Contractors) in regulated contexts.
• Proficiency with standard project management tools (Primavera P6, MS Project) and reporting platforms; advanced skills in MS Office with the ability to create executive‑level…