Project Manager – Quality Systems & Operations

Position Summary The Project Manager is responsible for leading cross-functional initiatives that support Quality Systems, Manufacturing Operations, Vendor Management, and Operational Excellence across multiple sites. This role serves as the central point of coordination between Quality, Manufacturing, Supply Chain, Engineering, Regulatory Affairs, IT, and external vendors to ensure projects are delivered on time while maintaining compliance with quality standards and organizational objectives. The successful candidate will oversee project execution, performance metrics, governance reporting, KPI development, process improvements, and quality initiatives while supporting manufacturing sites and vendor relationships. Primary Responsibilities Project Management • Lead medium to large cross-functional projects from initiation through implementation. • Develop project charters, timelines, milestones, budgets, and resource plans. • Monitor project risks and proactively develop mitigation strategies. • Coordinate project meetings and communicate status updates to leadership. • Ensure projects are completed on schedule and within scope. • Manage multiple concurrent projects across different business functions. Quality Systems Support the organization’s Quality Management System by: • Coordinating quality-related initiatives. • Supporting Quality Assurance programs. • Driving continuous improvement activities. • Maintaining compliance with internal procedures and regulatory requirements. • Assisting with implementation of new quality processes and systems. • Supporting audit readiness and corrective action initiatives. KPI & Performance Metrics Own and manage operational performance reporting including: • Development of Key Performance Indicators (KPIs) • Performance dashboards • Executive scorecards • Monthly operational reporting • Quality metrics • Vendor performance metrics • Manufacturing site metrics Analyze trends and identify opportunities for operational improvements. Manufacturing Site Support Partner with manufacturing locations to: • Coordinate quality improvement initiatives. • Support operational projects. • Standardize processes across manufacturing sites. • Resolve operational issues. • Track project deliverables affecting manufacturing operations. • Support implementation of new processes and systems. Serve as the liaison between corporate functions and manufacturing facilities. Vendor Management Work closely with external vendors by: • Coordinating project activities. • Tracking vendor deliverables. • Monitoring vendor performance. • Supporting vendor qualification and onboarding activities. • Escalating project risks and delays. • Ensuring vendors meet quality and timeline expectations. Maintain productive relationships with external partners and suppliers. Governance & Reporting Prepare and present project updates to senior leadership. Responsibilities include: • Governance meetings • Steering committee presentations • Executive reporting • Project dashboards • KPI reviews • Status reports • Risk logs • Action item tracking Process Improvement Identify opportunities to improve operational efficiency by: • Streamlining workflows • Standardizing documentation • Improving reporting processes • Eliminating bottlenecks • Implementing best practices • Supporting Lean or Six Sigma initiatives Cross-Functional Collaboration Collaborate closely with: • Quality Assurance • Manufacturing Operations • Engineering • Supply Chain • Regulatory Affairs • Validation • Information Technology • Procurement • External Vendors • Senior Leadership Required Qualifications • Bachelor’s degree in Engineering, Life Sciences, Business, or related discipline. • 8–10+ years of project management experience. • Experience supporting Quality Systems. • Experience managing cross-functional projects. • Strong organizational and communication skills. • Experience developing and managing KPIs. • Excellent analytical and problem-solving abilities. • Experience working in highly regulated industries. Preferred Qualifications • PMP Certification • Six Sigma Green Belt or Black Belt • Medical Device industry experience • Pharmaceutical or Biotechnology experience • Manufacturing Operations experience • Vendor Management experience • Quality Management Systems experience Preferred Technical Skills Experience with: • SAP • Microsoft Office Suite • Microsoft Project • Excel (advanced reporting) • Power BI (preferred) • Quality Management Systems (TrackWise, MasterControl, Veeva Quality, SolTraqs, or similar) • Dashboard and reporting tools Core Competencies • Project Planning • Stakeholder Management • Risk Management • Quality Assurance • Governance • Continuous Improvement • KPI Development • Vendor Management • Manufacturing Support • Executive Communication • Data Analysis • Cross-functional Leadership Success Measures Success in this role will be measured by: • On-time project delivery • Manufacturing site support effectiveness • Vendor performance improvements • KPI achievement • Quality metric improvements • Audit readiness • Stakeholder satisfaction • Continuous improvement implementation • Reduction in operational risks • Effective governance reporting