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Program Operational Readiness Senior Director

gsk · Upper Merion Biopharm

New
Senior 🇬🇧 English
GMP GxP Lean Management Data Integrity Design Management Project Schedule Scope Management Risk Management

Job description

About the role

The Program Operational Readiness Senior Director leads the operational readiness strategy and governance needed to move a major program from project delivery into safe, compliant and effective site operations. The role ensures the program's business case, site integration, cross-functional plans and business benefits stay aligned with enterprise, site, safety, quality, regulatory, financial and start-up objectives, and works with site leaders, global functions, external partners and executive governance to prepare the organization to receive, operate and sustain the new asset or infrastructure.

Key responsibilities

  • Keep program outcomes, objectives, benefits and the business case aligned with site and enterprise strategy
  • Lead the steering team building the future operating model (Quality, EHS, regulatory, HR, finance, supply chain, MSAT/technical, digital/automation, commercial, site operations)
  • Drive collaboration across steering teams including capital, Smart Manufacturing and Manufacturing Platform
  • Define readiness organization, governance, decision rights, escalation routes, forum cadence and accountable owners with the Project Director
  • Frame executive decisions with options, trade-offs, risks and recommendations, and protect the business case through control of scope, cost, schedule and changes
  • Secure resources, leadership capacity and organizational capability, and support first GMP and clinical manufacturing campaigns
  • Embed Quality, EHS, regulatory, engineering, validation, people, process, systems, training, maintenance and supply chain requirements from design through start-up and handover
  • Ensure sustainable transition to routine operations, including benefits realization and steady-state ownership

Required profile

  • 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, and with large-scale manufacturing capital build or transformation programs
  • Experience supporting design, construction, commissioning, qualification, validation, start-up and handover of major biopharmaceutical facilities, equipment and systems
  • GMP manufacturing and engineering experience

Preferred qualifications

  • Senior stakeholder leadership, governance discipline, strategic decision-making and executive communication
  • Benefits realization, resource and capability planning, and safety and quality mindset
  • Ability to lead through complexity, ambiguity and regulatory scrutiny

The role is based in the United States and is onsite. GSK does not accept referrals from employment agencies and requires prior written authorization for any referral.

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Source : ats:workday

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Published 12 hours ago

Expires 1 month from now

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gsk

Upper Merion Biopharm