Manager, Quality Systems Metrics and Management Review

Role Summary

The Manager of Quality Systems Metrics and Management Review is responsible for overseeing and refining enterprise performance review processes, driving effective metric reporting, and leading the automation and modernization of data review mechanisms and data consumption. This role enables leadership teams to make informed decisions through clear, timely, and actionable insights while advancing digital transformation in operational processes. It defines, implements, and monitors the performance of quality assurance systems across global internal manufacturing sites, third-party manufacturers, suppliers, and/or affiliates, and designs quality systems and processes to ensure compliance as well as efficiency throughout the global network. It may serve as a Quality Center of Excellence (COE) Lead, Business System Owner (BSO), and/or Business Process Owner (BPO) for a specified area within the Global Quality System.

Responsibilities

• Own and continuously improve the management review process, ensuring metrics are accurately collected, analyzed, and presented.
• Attend Regional and Global Management Review meetings as appropriate to ensure consistency and effective Knowledge Management.
• Develop and maintain performance dashboards and reporting mechanisms for leadership alignment.
• Lead initiatives to automate metrics gathering, reporting, and meeting workflows using modern digital tools.
• Collaborate cross-functionally to identify opportunities for increasing meeting efficiency and modernizing how data is consumed and shared.
• Interface with leadership teams and employees of both internal and external / supplier manufacturing sites to ensure connection and provide direction on quality assurance systems, processes, and procedures.
• Identify and lead quality system projects and oversee cross-functional project teams, collaborating closely with Business Technology Solutions (BTS) to implement strategic quality system enhancements to evaluate, implement, and maintain automation solutions related to data and meeting management driving consistency, efficiency, and compliance across sites and/or affiliates.
• Propose, design, and implement best practices for meeting effectiveness, including technology adoption and process reengineering.
• Monitor emerging trends in business intelligence, automation, and digital workplace tools to drive continuous improvement.
• Ensure compliance with company data governance and confidentiality policies. Lead quality system elements, continuous improvement, and tactical support across global functions, sites, and affiliates. Train stakeholders on new tools and processes to foster adoption and change management. Prepare and present data during regulatory inspections and internal audits.
• Interact with internal and external partners for development of best practices in our quality systems and procedures applicable to regulatory complexity across the global Operations network.
• Ensure all global product, process, and/or system related quality activities follow Corporate, governmental, and local regulations. Direct staff in planning, preparation, review, and approval of quality documentation.
• Establish process and training requirements within quality system area of responsibility to maintain business continuity and compliance in a changing environment. Lead or participate in quality system integrations as applicable.
• Lead a team of quality professionals across regions as necessary, including setting performance expectations as well as providing feedback and development. Ensure team has adequate resources and appropriate training to effectively support and meet changing business and compliance needs.

Qualifications

• Required: Knowledge of QA systems and GxP compliance requirements including regulations and standards applicable to medical devices, biologics, and/or pharmaceutical products.
• Required: Strong knowledge of business intelligence/reporting platforms (e.g., Power BI, Tableau, Spotfire, etc.) and digital collaboration tools (e.g., Teams, Zoom, workflow automation).
• Required: Experience leading process automation or digital transformation projects.
• Required: Excellent communication, presentation, and stakeholder management skills.
• Required: Analytical, detail-oriented, and proactive in driving organizational change.
• Preferred: Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area.
• Preferred: Minimum 7 years' experience in quality assurance, operations, regulatory or relevant experience.
• Preferred: Business analytics, metrics management, or process improvement roles, as well as experience in automation and change management.

Education

• Preferred: Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area.