Pharmaceutical - Senior Project Manager / PMO

Position Description

Summary:

We are seeking an experienced Senior Project Manager / PMO leader with a strong background in engineering or scientific disciplines and proven delivery experience within the pharmaceutical or biotech industry. This role is responsible for leading complex, cross-functional CAPEX projects (manufacturing, laboratories, utilities, engineering, construction) utilizing the best PMO standards, governance, and execution discipline.

This is a hands-on leadership role-not purely administrative-requiring ownership of project outcomes, stakeholder alignment, and technical understanding of regulated environments.

Responsibilities

Project Leadership & Delivery

• Lead end-to-end execution of capital projects, within pharmaceutical manufacturing and laboratories, from inception / business case development, through to project execution and closure.
• Manage many projects simultaneously (typically three to four), typically ranging between $1-10M, but the actual values may fluctuate (sometimes there are larger projects).
• Manage scope, schedule, cost, and quality across multiple concurrent projects, provide regular status updates & reporting on projects
• Drive project planning (charters, schedules, resource plans) and ensure realistic execution strategies
• Identify risks early and proactively manage mitigation plans in regulated environments.
• Escalate & resolve issues proactively.
• Document, manage and monitor action items, issues, decisions, risks.

PMO Governance & Standards

• Utilize world class PMO best practices, tools, and reporting structures for executing capital projects
• Work with project controls specialists on schedule tracking, cost forecasting, change management.
• Lead stage-gate processes aligned with GMP and validation requirements
• Provide portfolio-level visibility to leadership (KPIs, dashboards, resource loading)

Cross-Functional Coordination

• Requires interfacing / managing many stakeholders including engineering, construction, manufacturing, EHS, IT, QA, QC, Regulatory, maintenance, calibration, in a high paced manufacturing environment.
• Act as the central point of coordination between internal stakeholders and external vendors/contractors
• Manage third-party engineering firms, system integrators, and construction partners

Regulatory & Compliance

• Ensure projects align with U.S. Food and Drug Administration expectations and GMP requirements
• Oversee validation lifecycle activities (IQ/OQ/PQ), commissioning, and documentation readiness
• Maintain audit-ready project documentation

Stakeholder Management

• Communicate effectively with senior leadership and site-level teams
• Translate technical issues into business impacts and actionable decisions
• Drive accountability across teams without direct authority

Qualifications

Education

• Bachelor s degree in Engineering, Life Sciences, Scientific or related field
• Advanced degree (MBA, MS) is a plus

Certifications (Preferred, But Not Required)

• PMP (Project Management Professional) Project Management Institute

Experience

• 8 15+ years of project management experience
• 5+ years within pharmaceutical, biotech, or life sciences environments
• Demonstrated experience delivering capital projects, validation, manufacturing or compliance initiatives
• Experience working within or alongside a formal PMO

Technical & Industry Knowledge

• Strong understanding of GMP, validation, and regulated project environments
• Familiarity with systems such as MES, LIMS, ERP (e.g., SAP), or automation platforms is highly desirable, but not required.
• Experience with engineering design, construction, or process scale-up is highly desirable, but not required.

Core Competencies

• Strong execution mindset (not just reporting)
• Ability to manage ambiguity and drive decisions
• High accountability and ownership of outcomes
• Commercial awareness (cost, ROI, timelines)
• Ability to challenge stakeholders constructively
• Multi-tasking, escalating, reporting, tracking, documentation
• Working in a fast paced environment in a large organization