Global Quality Management System Governance and Operations Manager (Contract)

Vertex PharmaceuticalsBoston, MA
$70 - $80Onsite

About The Position

The Contractor, Global QMS Governance and Operations Support provides operational support for Global QMS Governance, analytics, data integrity/governance/quality, and select project management activities supporting QMS transition and future-state operations. This role partners cross-functionally with Quality and business stakeholders to support governance processes, reporting, documentation, workflow coordination, and execution of operational priorities.

Requirements

  • Strong organizational, coordination, and follow-up skills.
  • Strong technical writing, editing, and presentation development skills.
  • Experience supporting governance processes, reporting, and cross-functional teams.
  • Familiarity with QMS workflows and regulated documentation practices.
  • Familiarity with data integrity, data governance, and data quality concepts.
  • Experience with analytics, using Smartsheet for trackers, reporting, and action management.
  • Proficiency in Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams.
  • Strong verbal and written communication skills with attention to detail.
  • Ability to manage multiple priorities and work independently in a fast-paced environment.
  • Bachelor’s degree in Life Sciences, Quality, Business, Technical Communications, Information Management, or related field preferred.
  • Minimum 6 years of relevant experience in QMS support, quality operations, governance support, analytics/reporting, technical writing, or project management support.
  • Experience in a regulated environment required; biotechnology, pharmaceutical, medical device, or other GxP environment.

Nice To Haves

  • Experience supporting QMS operations, governance, process improvement, or transition initiatives preferred.

Responsibilities

  • Support Global QMS Governance activities, including meeting coordination, agenda development, minutes, action items, and follow-up tracking.
  • Provide operational support for QMS activities and selected transition-related initiatives.
  • Support analytics and reporting, including data gathering, tracking, summarization, dashboards, and recurring/ad hoc reports.
  • Assist with data integrity, data governance, and data quality activities to support reliable QMS data and reporting.
  • Support QMS workflow mapping coordination, including tracking key deliverables, approvals, and process follow-through.
  • May draft, edit, review or maintain business and technical documentation, including governance materials, SOPs, work instructions, process maps, meeting summaries, and training materials.
  • May develop PowerPoint presentations for governance forums, leadership updates, operational reviews, and project discussions.
  • Provide project management support for select initiatives, including timelines, trackers, risks/issues, and status updates.
  • Partner with SMEs and cross-functional stakeholders to support alignment of governance, reporting, and operational deliverables.

Benefits

  • compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
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