Serve as a senior Quality Systems professional supporting the Global Process Owner (GPO) for Nonconformance (NC) and CAPA processes across a global organization.Sustain and advance the global NC/CAPA program through governance support, process optimization, stakeholder engagement, data analysis, and system enhancements.Partner with Quality, Supply Chain, Operations, and Digital teams to improve process consistency, governance effectiveness, data quality, and global standardization.Key ResponsibilitiesGlobal Process & Governance SupportSupport ongoing sustainability and continuous improvement of global NC/CAPA processes.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, manage action items, identify roadblocks, and support issue resolution.Support global SOP updates, governance documentation, training materials, process communications, and deployment activities.STAR Network CoordinationCoordinate and facilitate monthly STAR Network meetings, including agenda creation, meeting management, and follow-up actions.Maintain STAR Network communication channels and respond to process-related inquiries.Support quarterly Global STAR Network meetings and stakeholder engagement initiatives.NC/CAPA Data Analysis & ReportingReview NC/CAPA quality metrics and performance data on a monthly basis.Analyze trends, recurring quality issues, governance gaps, and process performance indicators.Develop recommendations and insights to support CAPA Council discussions and leadership decision-making.Create executive-level reports, dashboards, presentations, and summaries.Comet Process & System SupportSupport Comet NC/CAPA module enhancements, testing, releases, user story development, and change management activities.Coordinate communications related to system updates, deployment timelines, business impacts, and hypercare support.Collaborate with stakeholders to identify process and system improvement opportunities.CAPA Review Board (CRB) Governance & StandardizationDevelop and maintain a comprehensive inventory of CAPA Review Boards (CRBs) across the organization.Establish ownership structures and key points of contact for each review board.Assess governance models, identify ownership gaps, and evaluate organizational coverage.Facilitate communities of practice and drive standardization across review boards.Data Quality & Failure Mode OptimizationPartner with Supply Chain and platform teams to improve failure mode structures and quality data classification within Comet.Identify opportunities to enhance master data quality, consistency, and reporting capabilities.Support implementation, deployment, and hypercare activities for process and data quality improvements.Required Skills & Experience8+ years of experience in Quality Excellence, Quality Compliance, or Process Excellence.Expertise in Nonconformance (NC), CAPA, Quality Management Systems (QMS), Quality Governance, and Process Ownership.Experience supporting global quality processes, governance forums, review boards, councils, or cross-functional quality programs.Strong analytical skills with the ability to interpret complex data, identify trends, and make actionable recommendations.Advanced Microsoft Excel proficiency.Experience developing executive-level presentations, reports, and dashboards.Excellent facilitation, communication, organization, and stakeholder management skills.Nice to Have Skills & ExperienceExperience with Comet, TrackWise, Veeva, ETQ, MasterControl, or similar Quality Management Systems.Pharmaceutical, biotechnology, medical device, or other highly regulated industry experience.Experience supporting global process owners and enterprise-wide 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.
about 1 month ago