Director Sterile Operational Quality Assurance

About the role

The Director of Sterile Operational Quality Assurance leads Teva’s sterile manufacturing quality program at the Kfar Saba site. This senior position provides strategic direction, ensures regulatory compliance, and drives continuous improvement across all aseptic operations.

Key responsibilities

• Lead the sterile QA organization, managing team development and execution of quality strategies.
• Oversee critical quality systems including deviations, investigations, CAPA, change controls, complaints, and batch review.
• Provide expert oversight of aseptic manufacturing processes (Grade A/B/C, isolators, validations, environmental monitoring) in line with EU GMP Annex 1.
• Drive inspection readiness and act as primary QA contact for FDA, EMA, and local regulatory audits.
• Collaborate cross‑functionally with Operations, Engineering, QC, Supply Chain, and Global QA to ensure alignment with business objectives.
• Monitor KPIs, identify gaps, and lead continuous‑improvement initiatives.

Required profile

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering or related field; Master’s preferred.
• 12+ years of pharmaceutical QA experience, with at least 7 years in sterile/aseptic operations.
• Proven leadership of QA teams in complex sterile production environments.
• Strong knowledge of global GxP regulations (FDA, EMA, ICH) and sterile manufacturing expectations.
• Demonstrated success in managing regulatory inspections and interactions.

Required skills

• Experience with global Quality Management Systems such as Veeva.
• Experience with TrackWise or similar CAPA/Change Control platforms.

What we offer

• Comprehensive benefits designed to support health and work‑life balance.
• Opportunities for professional growth within a leading biopharmaceutical company.