About The Position

The Director of Quality Governance & Operational Excellence ensures the integrity, consistency, and accessibility of quality data across the enterprise while leading cross-functional response to hyper care and strategic initiatives that support agility, simplification, and continuous improvement. This role is a key driver of digital quality tool integration, cross-functional problem-solving, and enterprise-wide readiness for change and innovation. This role partners closely with IT, Quality, R&D, Regulatory, and Operations to drive adoption of digital quality tools, standardize reporting, and strengthen problem-solving capabilities across the network. This position plays a critical role in enabling data-driven decision-making, improving system utilization, and supporting enterprise readiness for change, but operates with shared ownership and collaboration rather than sole enterprise accountability.

Requirements

  • Bachelor's Degree in a scientific, technical, or engineering discipline (Required)
  • 10+ years in Quality Assurance, Quality Systems, or Regulatory Compliance in a regulated manufacturing environment (OTC, cosmetics, pharma, or personal care) (Required)
  • 10+ years working with quality systems, data reporting, and/or digital tools (Required)
  • 10+ years supporting cross-functional projects and problem-solving efforts (Required)
  • 10+ years communication and collaboration skills (Required)

Nice To Haves

  • 10+ years in a multi-site or contract manufacturing environment (Preferred)
  • 10+ years familiarity with QMS tools (QT9, ETQ, LIMS, Valdata, etc.) (Preferred)
  • 10+ years lean Six Sigma or continuous improvement (Preferred)

Responsibilities

  • Drive standardization of quality data definitions, reporting, and KPIs across sites, support development and maintenance of dashboards and metrics for deviations, complaints, OOS, and audit findings, partner with site quality teams to improve data accuracy, consistency, and usability, and identify gaps and opportunities in current reporting processes and recommend improvements
  • Support implementation and enhancement of digital quality systems (QT9, Fix, LIMS, Valdata) in partnership with IT and site teams, contribute to the digital quality roadmap, including system upgrades, integrations, and process improvements, ensure systems are aligned with cGMP and data integrity expectations and drive user adoption and reduce reliance on manual reporting processes
  • Support and help lead cross-functional response to quality issues and escalations, facilitate structured problem-solving (5 Whys, Fishbone, A3) and root cause analysis efforts, partner with site and functional leaders to drive timely resolution and preventive actions and provide clear updates and reporting on issue status, risks, and mitigation plans
  • Lead or support enterprise initiatives focused on simplification, process improvement, and speed-to-market, partner with cross-functional teams on transformation efforts and system enhancements, identify opportunities for automation, efficiency, and improved integration across processes and contribute to continuous improvement efforts across the Quality organization
  • Support oversight and coordination of the corporate New Product Stability Program, partner with R&D, Regulatory, and site teams to ensure timely execution and reporting, drive consistency and standardization across sites and monitor program performance and identify improvement opportunities
  • Track and report KPIs, including: Digital tool adoption and utilization, Quality issue response and resolution timelines, Stability program execution performance, Reduction in manual reporting and redundancies and Progress on quality-related projects
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