Director Sterile Operational Quality Assurance
Kfar Saba, Israel, 4410202
We Are Teva
Our Team, Your Impact
The Director of Sterile Operational Quality Assurance is responsible for providing strategic leadership, direction, and oversight for all Quality Assurance activities related to sterile manufacturing at the Kfar Saba site. This role ensures compliance with global regulatory requirements (FDA, EMA, EU‑GMP, Annex 1) and Teva Quality Standards while fostering a culture of quality, continuous improvement, and inspection readiness.
The role leads the sterile QA organization, supports routine operations, manages critical quality systems, and partners cross‑functionally to maintain a robust aseptic operation aligned with Teva’s business objectives and “Pivot to Growth” strategy.
How You’ll Spend Your Day
- Leadership & Strategy
Lead Sterile Operational QA, including team management, development, and execution of quality strategies to ensure compliance, supply reliability, and continuous improvement. - Quality Systems & Compliance
Oversee key quality systems (deviations, investigations, CAPA, change controls, complaints, batch review) and approve critical documents and regulatory responses. - Aseptic & Sterile Oversight
Provide expert oversight of aseptic manufacturing (Grade A/B/C, isolators, validations, environmental monitoring) in line with EU GMP Annex 1. - Regulatory Inspections
Lead inspection readiness and serve as primary QA contact for regulatory audits (FDA, EMA, MoH). - Cross-Functional Collaboration
Partner with Operations, Engineering, QC, Supply Chain, and Global QA to drive alignment and operational excellence. - Continuous Improvement
Monitor KPIs, identify gaps, and lead ongoing quality and performance improvements.
Your Skills and Experience
- Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field; Master’s degree preferred.
- 12+ years of experience in pharmaceutical Quality Assurance, with at least 7 years in sterile / aseptic operations.
- Proven experience leading QA teams and managing complex sterile production environments.
- Strong knowledge of global GxP regulations (FDA, EU GMP, ICH) and sterile manufacturing regulatory expectations.
- Demonstrated success in inspection management and regulatory interaction.
- Experience with global Quality Management Systems (e.g., Veeva, TrackWise).
Salary Range
How We’ll Take Care of You
Reports To
Sr Dir, Site Quality Head
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