Emily Roberts

About Emily Roberts

Quality systems and compliance leader with 17+ years of experience in regulated manufacturing environments, including division-level quality governance across multi-site operations. Background includes medical devices and pharmaceutical primary packaging supporting biotech and biopharmaceutical customers in GMP-aligned environments.Experienced in building and governing large-scale Quality Management Systems (ISO 13485 / 15378 / 9001 / CGMP), driving inspection readiness, and leading supplier and CMO quality oversight programs including qualification, auditing, performance management, and corrective action. Serves as division Quality Management Representative across 15 global sites, establishing standardized processes, KPIs, and audit frameworks in a matrix environment.Proven track record leading high-performing quality organizations (50+ employees), supporting manufacturing start-ups, validation and technology transfer activities, and implementing digital QMS transformation initiatives (ETQ, KPI automation, Power BI reporting). Strong experience hosting customer and notified body audits and participating in regulatory inspections in support roles.Strengths include cross-functional leadership, risk-based decision making, quality system harmonization, and continuous improvement through Lean, Six Sigma, and data-driven performance management. Committed to building accountable, metrics-driven quality cultures that balance compliance, operational excellence, and business performance.

Experience

1. Life Sciences Division Quality Manager

   Corning Incorporated

   Nov 2023 — Present · Durham, NC, US

   Division ISO 13485 and 9001 Management Representative across 15 global sites supporting life sciences, biotech, and pharmaceutical customers; provides quality system governance, direction, and oversight without direct line management responsibility. • Oversees division-wide QMS programs including CAPA, deviations, change control, risk management, training, internal audits, management review, and field actions, setting required processes and performance expectations for all sites. • Participates in regulatory inspection readiness program; oversees all certification and surveillance audits. • Leads division-level continuous improvement initiatives focused on risk reduction and operational excellence through standards harmonization, deployment of automated KPI metrics reporting, and crossfunctional collaboration. • Owns and governs the division’s electronic QMS (ETQ), including system design strategy, validation oversight, and quality compliance oversight of integrations with ERP/MES and design control systems. • Established a centralized global internal audit program, reducing audit hours by 55% while improving early detection of compliance risks. • Led FDA QMSR transition activities and guided multiple sites through ISO certification upgrades, including ISO 9001 to ISO 13485 transitions.