Operational Readiness Project Manager, Quality, CGT (Contract)

Vertex PharmaceuticalsBoston, MA
4d$85 - $95Onsite

About The Position

The Cell and Gene Therapy Quality organization is seeking an Operational Readiness Project Manager to support operational readiness governance and site Quality continuous improvement initiatives. This role will be split approximately 50/50 between Operational Readiness and Continuous Improvement project execution. The Project Manager will own the planning, execution and follow-up of site-wide operational readiness governance forums. They will be responsible for meeting coordination, action assignment/tracking, and stakeholder management to ensure the overall operational readiness timelines are met. The project manager will also support moderate complexity kaizen and continuous improvement initiatives. The ideal candidate brings a blend of strategic thinking, hands-on-execution and data driven problem solving skills in a regulated environment. This is a 12 month contract role No direct reports. On site role at Leiden Center location.

Requirements

  • 5+ years of experience in Continuous Improvement, Project Management, or a combination in pharmaceutical, biotech or other regulated industries.
  • Bachelor’s degree in engineering or related Life Sciences degree.
  • Demonstrated experience supporting cross-functional governance models, or complex, matrixed initiatives.
  • Stronge change management experience
  • Experience with PowerBI or similar data visualization tools strongly preferred.
  • Experience applying structured problem solving (e.g. 3C, 8 Step, DMAIC, PCDA, etc) and continuous improvement tools (e.g. Kamishibai, Kanban, 5S, Poke Yoke, etc).
  • Application of Lean or Six Sigma methodologies (Green Belt Certification preferred)
  • Excellent communication and stakeholder management skills.
  • Proficiency with common project management tools (e.g. MS Project, Smartsheet)
  • Proficiency with Microsoft Office.

Responsibilities

  • Lead the planning, coordination and facilitation of operational readiness governance forums in support of commercial launch activities.
  • Partner with workstream leads to develop and maintain integrated readiness plans, timelines, and trackers.
  • Drive cross-functional alignment by coordinating inputs, documenting decisions, tracking action items and escalating risks.
  • Partner with functional leads to assess readiness status, identify gaps, and support mitigation planning.
  • Prepare clear and concise governance materials, including agenda, status updates, risk register, decision logs and open action tracking.
  • Execute moderate complexity operational excellence and continuous improvement projects.
  • Support and facilitate kaizen events, problem solving workshops, and process improvement initiatives.
  • Apply Lean, Six Sigma, or other continuous improvement methodologies to identify inefficiencies, address root cause and improve operational performance.
  • Develop data driven insights and performance dashboards to support decision-making and track improvement outcomes.
  • Leverage PowerBi (preferred) or similar tools to analyze quality operational data, visualize trends, and communicate results.
  • Sustain process improvements by effectively documenting new processes, implementing standard work and socializing improvement outcomes.
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