Job Title: Global QMS Governance and Operations Support Consultant
Contract: 12+ Months
Location: Boston, MA - Hybrid
Description:
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.
Key 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.
Knowledge and Skills:
- 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.
Education and Experience:
- 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.
- Experience supporting QMS operations, governance, process improvement, or transition initiatives preferred.
Pay: $70.00 - $75.00 per hour
Work Location: In person
