Program Operational Readiness Senior Director

Position Summary

The Program Operational Readiness Senior Director is accountable for leading the operational readiness strategy and governance required to transition a major program from project delivery into safe, compliant, and effective site operations. This role ensures the program business case, site integration, cross-functional plans, and defined business benefits remain aligned with enterprise, site, safety, quality, regulatory, financial, and start-up objectives. The role partners with site leaders, global functions, external partners, and executive governance to confirm that the organization is prepared to receive, operate, and sustain the new asset or infrastructure. This includes ensuring that people, processes, systems, safety controls, training, and business arrangements are ready from handover through go-live, stabilization, and delivery of expected performance outcomes.

Responsibilities

• Ensure program outcomes, objectives, benefits, and the business case remain aligned with site and enterprise strategy.
• Lead the steering team responsible for developing the future operating model including Quality, EHS, regulatory, HR, finance, supply chain, MSAT/technical, digital/automation, commercial, and site operations.
• Drive collaboration across steering teams inclusive of capital, Smart Manufacturing, and Manufacturing Platform to maintain alignment to the endorsed strategic vision.
• Define program readiness organization, governance, decision rights, capability requirements, escalation routes, forum cadence, accountable owners, and decision-ready information in partnership with the Project Director.
• Frame executive decisions with clear options, trade-offs, risks, recommendations, and sponsor actions to enable timely governance decisions.
• Define and govern strategic risk appetite, major issue escalation, and risk-based decision making across business, delivery, readiness, compliance, and operational risks.
• Protect the business case with the Project Director through disciplined control of scope, cost, schedule, contingency, major change decisions, and delivery of the approved program ambition.
• Secure the resources, leadership capacity, and organizational capability required to deliver the program and sustain the future operating model.
• Deliver readiness for first GMP and clinical manufacturing campaigns by embedding site operational readiness as a core workstream aligned with project scope, schedule, acceptance criteria, transition requirements, and steady-state ownership.
• Support facility design, startup, CQV, operational handover, and readiness by ensuring Quality, EHS, regulatory, engineering, validation, technical, people, process, systems, training, maintenance, and supply chain requirements are embedded from design through start-up.
• Ensure sustainable transition into routine operations through stakeholder communication, business acceptance, handover readiness, steady-state ownership, post-start-up benefits realization, and disciplined execution through ambiguity, capital exposure, regulatory scrutiny, and operational risk.

Basic Qualifications

• Bachelor’s degree or equivalent practical experience in engineering, project management, construction management, operations, or a scientific discipline.
• Minimum 10 years’ experience in operational readiness, manufacturing operations, or program delivery in the pharmaceutical industry.
• Experience in commissioning/start-up and capital project delivery.
• Experience with large-scale manufacturing capital build or transformation programs.
• Experience supporting design, construction, commissioning, qualification, validation, start-up, and operational handover of major biopharmaceutical manufacturing facilities, equipment, and supporting systems.
• Experience managing capital project interfaces.
• GMP manufacturing and engineering experience.

Preferred Qualifications

• Strong senior stakeholder leadership, governance discipline, strategic decision-making, capital risk management, executive communication, cross-functional integration, benefits realization, resource and capability planning, safety and quality mindset, and ability to lead through complexity, ambiguity, and regulatory scrutiny.
• Strong organizational skills and communication skills are a must.
• Strong relationship management skills, with the ability to interact, influence, and manage multiple stakeholders.

Work Arrangement

This role is based in the United States and onsite.