15 oct
|
Novartis
|
Zaragoza
Salary Range:
€45,100.00 - €83,700.00
Band
Level 4
Job Description Summary
LI-Onsite
Location: La Almunia de Doña Godina (Zaragoza, Spain)
This role is La Almunia de Doña Godina, Spain. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
The Quality Assurance Operations Lead plays a critical role in ensuring that products are released with the highest standards of quality, compliance, and patient safety. This role oversees the release of sterile injectable products manufactured in line with the Quality System, current registrations, GMP, EMA, AEMPS, the Novartis Quality Manual, and all applicable regulatory requirements.
As a key quality leader on site, the position provides strategic oversight of manufacturing operations, ensuring that commercial activities remain fully compliant and inspection-ready. The role also leads the people, processes, and technical resources within the Quality Assurance Operations department, driving effective QA support, continuous improvement,
and a strong quality culture across site operations.
Job Description
Deadline for applications: 29th October 2026.
Major Accountabilities:
• Lead the implementation and continuous improvement of compliance with applicable quality standards, including GMP, AEMPS,EMA the Novartis Quality Manual, and site quality procedures, while promoting a strong quality culture across the organization.
• Oversee QA Operations activities, including product release, documentation management, SOP approval, training, resource planning, shift organization for QPs and QA Officers, and professional development of team members.
• Ensure quality oversight of manufacturing operations, maintenance, qualification, calibration, revalidation, process validation, cleaning validation, equipment qualification, and new projects requiring QA Operations support.
• Manage and approve quality processes including OOS, OOT, OOE, deviations, change controls, CAPA
📌 Quality Assurance Operations Lead (Zaragoza)
🏢 Novartis
📍 Zaragoza