Quality Assurance Operations Lead

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.

About the Role 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, complaints, recalls, returns, investigations, and related corrective and preventive actions in accordance with cGMP and SOPs.Ensure timely escalation and communication of quality and cGMP issues, non-conformities, product-impacting incidents, and substantial irregularities involving products already placed on the market, including communication to relevant internal stakeholders and competent authorities when required.

Support audits, inspections, and quality reviews by participating in authority and corporate audits, annual self-inspection planning, annual training planning, and Annual Product Quality Review preparation and review.

Monitor, report, and drive quality performance by tracking assigned indicators, ensuring projects and responsibilities are completed on time, and supporting business continuity in collaboration with Site Management, Quality, Quality Control, and Production leaders.

Provide QA support to commercial operations while ensuring compliance with environmental, safety, order, cleanliness, internal communication, and external communication requirements within the area of responsibility.

Obligatory Requirements:

Scientific degree in Pharmacy, Chemistry, or Biology5+ years of experience in the pharmaceutical industry, with strong knowledge of QA Operations and quality requirements.

Strong understanding of cGMP regulations, regulatory requirements, and pharmaceutical quality standards.

Solid knowledge of aseptic processes and aseptic manufacturing practices.

Excellent organizational skills, attention to detail, teamwork mindset, and ability to work with urgency on assigned tasks.

Strong communication and collaboration skills, with the ability to support smooth and safe production operations, drive productivity improvements through new technologies and processes.

Fluent in Spanish and English, both written…