This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted. This role is hybrid in Boston.

Role Overview
We are seeking a QMS Governance and Operations Support Contractor to provide support across quality governance, documentation, reporting, data tracking, and project coordination activities. This role will help support QMS processes, operational follow-up, workflow coordination, and cross-functional communication in a regulated environment.

Key Responsibilities

• Support QMS governance activities, including meeting coordination, agendas, minutes, action items, and follow-up.
• Assist with QMS operations, transition activities, workflow tracking, and process coordination.
• Support reporting and analytics, including data gathering, dashboards, trackers, summaries, and status updates.
• Help maintain accurate QMS data through data integrity, governance, and quality support.
• Draft, edit, review, and maintain documentation such as SOPs, work instructions, process maps, meeting summaries, and training materials.
• Develop presentations for governance meetings, leadership updates, operational reviews, and project discussions.
• Provide project coordination support, including timelines, action logs, risks/issues, and deliverable tracking.
• Partner with cross-functional stakeholders to support alignment, communication, and follow-through.

Required Qualifications

• 6+ years of relevant experience in QMS support, quality operations, governance, reporting, technical writing, or project coordination.
• Experience working in a regulated environment, such as biotech, pharmaceutical, medical device, or another GxP setting.
• Familiarity with QMS processes, regulated documentation, SOPs, work instructions, and process mapping.
• Strong writing, editing, presentation, organization, and follow-up skills.
• Experience supporting cross-functional teams, meetings, reporting, and action tracking.
• Proficiency with Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams.
• Ability to manage multiple priorities and work independently in a fast-paced environment.

Preferred Qualifications

• Bachelor’s degree in Life Sciences, Quality, Business, Technical Communications, Information Management, or a related field.
• Experience supporting QMS transitions, process improvement, or operational initiatives.
• Familiarity with data integrity, data governance, analytics, dashboards, and reporting tools.
• Experience using Smartsheet or similar project tracking tools.