Tali Ben Nun
Irvine
Summary
Strategic Quality and Operations Executive with 18 years of experience leading multisite organizations globally. Expertise in FDA QSR, EU MDR, ISO 13485, and regulatory frameworks for pharmaceuticals and biologics. Drives quality strategy, harmonizes quality management systems, and fosters cross-functional collaboration. Focused on building high-performing teams and enhancing quality culture to improve compliance and product reliability.
Overview
21
21
years of professional experience
Work History
Head of Quality, North America Operations
Teva Pharmaceuticals
11.2025 - Current
- Led Quality strategy and compliance across North America, overseeing 10 operational sites and a Quality organization of 400+ employees to ensure alignment with FDA QSR and global regulatory expectations.
- Oversaw the quality operations for medical devices across North America, ensuring compliance with all regulatory standards.
- Ensured adherence to quality standards across all North American operations, driving consistent product excellence.
- Strengthened core quality processes (deviations, CAPA, change control, complaints, risk management) and established governance to enhance issue resolution and trending analysis.
- Drove inspection readiness, remediation, and regulatory engagement across multiple sites, partnering with agencies and internal stakeholders to maintain supply and compliance.
- Hired and developed quality leadership, implemented performance metrics, and established accountability mechanisms to cultivate a robust quality culture.
- Led and mentored a team, demonstrating strong supervisory skills to enhance overall quality performance in North America.
- Collaborated with Manufacturing, Supply Chain, R&D, and Regulatory to address complex product quality issues and enhance product lifecycle management.
- Represented North America Quality in global governance forums and enterprise decision-making.
Senior Director, Global Quality Systems (Corporate)
Teva - USA
10.2022 - 07.2026
- Executive owner of Teva's global Quality System, ensuring harmonized implementation across 35 global manufacturing sites, R&D centers, and business units.
- Led global deployment of Quality System 2.0 and managed lifecycle of corporate standards, ensuring consistent QMS practices across all sites.
- Oversaw risk management, supplier quality, and computerized systems compliance, defining global KPIs that enhanced inspection readiness across the network.
- Implemented QMS elements aligned with FDA QSR (21 CFR 820), EU MDR 2017/745, ISO 13485, and ISO 14971.
- Business lead for Veeva Vault; strengthened computerized systems compliance and digital quality capabilities.
- Delivered cost-saving initiatives through optimized resource allocation and governance, enhancing employee engagement through targeted coaching and leadership development.
Senior Director, Site Quality Head - Sterile Manufacturing
Teva Pharmaceuticals
Irvine
06.2020 - 09.2023
- Head of Site Quality for a sterile injectables facility; accountable for site quality strategy, compliance, and leadership of ~100 Quality professionals.
- Co-led FDA inspections, ensuring full GMP compliance in sterile manufacturing and batch release operations.
- Oversaw batch release, investigations, CAPA, change control, and laboratory oversight, safeguarding product integrity and ensuring market supply.
- Partnered cross-functionally to resolve complex quality issues, support new product introductions, and improve product reliability.
- Led site closure activities, maintaining compliance and operational continuity while enhancing site quality culture through coaching and communication.
Senior Director, Head of Quality Assurance - Sterile and OSD
Teva Pharmaceuticals
Kfar Saba
01.2017 - 06.2020
- Led QA for sterile and oral solid dosage operations, overseeing ~300 employees and ensuring compliance with FDA, EMA, and global regulatory agencies.
- Co-led multiple FDA inspections, including a PAI for a biologic combination product.
- Oversaw the quality operations for medical devices and combination products, ensuring compliance with all regulatory standards.
- Established and operated biological and device laboratories, partnering with global R&D on new product introductions for sterile and combination products (injectable fill-finish, device packaging, visual inspection systems) to enhance product quality and compliance.
- Served as Interim Site Quality Head for 2+ years, maintaining oversight of QA, QC, and Quality Systems.
- Directed business transformation (OPEX) programs, resulting in improved operational performance and alignment with strategic profitability goals.
Technical Operations Leader - OTC (APAC and LATAM)
Teva Pharmaceuticals
Petach Tikva
01.2016 - 01.2017
- Led validation and technical operations for APAC and LATAM markets, facilitating successful product launches with contract manufacturers.
- Managed project plans, timelines, and budgets to deliver regional launches and technical transfers.
- Collaborated with Supply Chain, Marketing, R&D, Strategy, and Operations to align product and network requirements, ensuring seamless market integration.
- Conducted supplier due diligence and qualification in China and India, enhancing OTC supply chain reliability.
Head of Regional Transfer and NPI - Supply Chain (EU and IL)
Teva Pharmaceuticals
Petach Tikva
01.2014 - 01.2016
- Managed new product introduction (NPI) and API supply resolution, ensuring timely product launches and uninterrupted supply.
- Led annual operating planning (AOP) across 10 sites in Europe and Israel and drove S&OP and cost-saving initiatives across the region.
- Aligned product strategy with network planning and global operations, supporting key business priorities.
Head of Sterile Production (Biologics, PFS, Eye Drops, Vials)
Teva Pharmaceuticals
Kfar Saba
01.2011 - 01.2014
- Led ~160 staff in sterile production and training for biologics, prefilled syringes, eye drops, and vials, enhancing operational capability.
- Introduced new products while overseeing installation and qualification of two new production lines, expanding production capacity.
- Drove continuous improvement initiatives and contributed to the site's strategic direction.
- Managed sterile product packaging operations, including device packaging lines and visual inspection, ensuring compliance with quality standards.
Section Manager / Team Leader - Sterile Production
Teva Pharmaceuticals
Kfar Saba
01.2008 - 01.2011
- Led 20-60 staff in sterile vial production, ensuring strict adherence to aseptic practices and comprehensive training compliance.
- Provided validation support and established performance metrics to enhance productivity and optimize staffing efficiency.
- Managed cross-functional teams to ensure compliance with quality standards.
- Developed and implemented strategies to optimize production processes.
- Oversaw inventory management and ensured timely supply of materials.
Patent Examiner
Israel Patent Office
01.2006 - 01.2008
- Reviewed patent applications, assessing scientific claims for novelty and patentability to ensure compliance with legal standards.
- Collaborated with legal and technical experts to determine examination outcomes, facilitating informed decision-making in patent approvals.
- Reviewed patent applications for compliance with legal and technical standards.
- Conducted prior art searches to assess patentability of inventions.
- Collaborated with inventors to clarify technical aspects of applications.
Education
M.A. - Law Studies
BarIlan University
B.Sc. - Biotechnology
BarIlan University
Skills
- Core Competencies
- Quality systems
- Risk management
- Compliance audits
- Regulatory compliance
- Global Quality Leadership and Governance, Quality Management System (QMS) implementation, Sterile Manufacturing and Aseptic Operations, Quality Systems (Deviations, CAPA, Change Control, Risk Management), FDA QSR (21 CFR 820), EU MDR 2017/745, ISO 13485, ISO 14971, Supplier Quality and Computerized Systems (Veeva Vault, TrackWise, LIMS), Operational Excellence, KPI Management, Continuous Improvement, Product Quality Management (pharmaceuticals, sterile biologics, combination/device products), Inspection Readiness (FDA, EMA, global agencies), Cross-Functional Collaboration with R&D, Operations, and Regulatory
Languages
English, Hebrew
Timeline
Head of Quality, North America Operations
Teva Pharmaceuticals
11.2025 - Current
Senior Director, Global Quality Systems (Corporate)
Teva - USA
10.2022 - 07.2026
Senior Director, Site Quality Head - Sterile Manufacturing
Teva Pharmaceuticals
06.2020 - 09.2023
Senior Director, Head of Quality Assurance - Sterile and OSD
Teva Pharmaceuticals
01.2017 - 06.2020
Technical Operations Leader - OTC (APAC and LATAM)
Teva Pharmaceuticals
01.2016 - 01.2017
Head of Regional Transfer and NPI - Supply Chain (EU and IL)
Teva Pharmaceuticals
01.2014 - 01.2016
Head of Sterile Production (Biologics, PFS, Eye Drops, Vials)
Teva Pharmaceuticals
01.2011 - 01.2014
Section Manager / Team Leader - Sterile Production
Teva Pharmaceuticals
01.2008 - 01.2011
Patent Examiner
Israel Patent Office
01.2006 - 01.2008
M.A. - Law Studies
BarIlan University
B.Sc. - Biotechnology
BarIlan University