Program Operational Readiness Senior Director

gsk; Upper Merion Township (Montgomery County); On-site; USD 190,000 - 260,000; Full time

Job summary

GSK in the United States is seeking a Program Operational Readiness Senior Director to lead the operational readiness strategy for a major program, guiding handover to site operations and ensuring readiness through go-live and steady-state performance.

You will partner with site leadership, global functions, external partners, and executive governance to align the program business case, governance, and readiness activities with safety, quality, regulatory, and financial objectives, while

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.

Responsibilities

• Lead the program readiness organization, governance, decision rights, capability requirements, escalation routes, and information delivery with the Project Director.
• Define and govern the future operating model across Quality, EHS, regulatory, HR, finance, supply chain, and site operations.
• Drive cross-functional collaboration to maintain alignment with the endorsed strategic vision across capital, Smart Manufacturing, and Manufacturing Platform.
• Frame executive decisions with options, risks, and sponsor actions for timely governance approvals.
• Ensure resources, leadership, and organizational capability to deliver the program and sustain the operating model.
• Deliver readiness for GMP and clinical manufacturing campaigns through handover to routine operations.

Skills

Construction Management

Data Integrity

Design Management

Digital Fluency

GxP Regulations

Lean Management

Manufacturing Technologies

Pharmaceutical Manufacturing

Problem Solving

Project Schedule

Risk Awareness

Scope Management

Education

Bachelor's degree or equivalent practical experience in engineering, project management, construction management, operations, or a scientific discipline

Job description

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.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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.

Why You? Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 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

If you have the following characteristics, it would be a plus:

• 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.

#LI-GSK

Skills

Construction Management, Data Integrity, Design Management, Digital Fluency, GxP Regulations, Lean Management, Manufacturing Technologies, Pharmaceutical Manufacturing, Problem Solving, Project Schedule, Risk Awareness, Scope Management

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at [e-mail]

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.