Global NC/CAPA Process & Governance Consultant

Seeking a senior Quality Systems professional to support the Global Process Owner (GPO) for Nonconformance (NC) and CAPA processes. This individual will help sustain and advance the global NC/CAPA program through governance support, process optimization, data analysis, stakeholder engagement, and Comet system enhancements.
This role will act as a key liaison across Quality, Supply Chain, Operations, and Digital teams to improve process consistency, strengthen governance, optimize data quality, and drive standardization across the global network.
Key Responsibilities
Global Process & Governance Support
Support ongoing sustainability and advancement of the global NC/CAPA process.
Partner directly with the Global Process Owner (GPO) on governance initiatives, process improvements, communications, and implementation activities.
Facilitate weekly Global NC/CAPA Process Team meetings, track actions, identify roadblocks, and support issue resolution.
Support global SOP updates, governance documentation, training materials, communications, and process deployment activities.
STAR Network Coordination
Coordinate monthly STAR Network meetings, including agenda development, meeting management, and follow-up actions.
Maintain the STAR Network communication channels and respond to process questions from the broader organization.
Support quarterly Global STAR Network meetings and stakeholder engagement activities.
NC/CAPA Data Analysis & Reporting
Review NC/CAPA data and quality metrics on a monthly basis.
Analyze trends, recurring quality issues, governance gaps, and process performance indicators.
Develop insights and recommendations to support CAPA Council discussions and senior leadership requests.
Prepare reports, presentations, dashboards, and executive summaries.
Comet Process & System Support
Support Comet NC/CAPA module enhancements, releases, testing, user story development, and change management activities.
Coordinate communications regarding system updates, impacts, deployment timelines, and hypercare support.
Partner with business stakeholders to identify opportunities for process and system improvements.
CAPA Review Board (CRB) Governance & Standardization
Build a comprehensive inventory of CAPA Review Boards (CRBs) across the organization.
Establish and maintain ownership structures and points of contact for each review board.
Assess governance models, identify ownership gaps, and evaluate organizational coverage.
Facilitate communities of practice and drive standardization efforts across review boards.
Data Quality & Failure Mode Optimization
Partner with Supply Chain and platform teams to improve failure mode structures and quality data classifications within Comet.
Identify opportunities to improve master data quality, consistency, and trendability.
Support implementation and hypercare activities associated with process and data improvements.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

8+ years of experience in Quality Systems, Quality Excellence, Quality Compliance, or Process Excellence.
Strong expertise in:
Nonconformance (NC)
CAPA
Quality Management Systems
Quality Governance
Process Ownership
Experience supporting global quality processes, review boards, councils, or governance forums.
Strong data analysis skills with the ability to interpret trends and provide recommendations.
Advanced Microsoft Excel skills.
Experience preparing executive-level reports, dashboards, and presentations.
Strong facilitation, organization, and stakeholder management skills.

Experience with Comet, TrackWise, Veeva, ETQ, MasterControl, or similar Quality Management Systems.
Pharmaceutical, biotech, medical device, or other highly regulated industry experience.
Experience supporting global process owners or enterprise quality programs.

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.