Quality Assurance Operations Lead

ES45 (FCRS = ES045) Advanced Accelerator Applications Iberica S.L.U.; Zaragoza; On-site; EUR 45,000 - 84,000; Full time

Job summary

Novartis is seeking a Quality Assurance Operations Lead for La Almunia de Doña Godina, Spain. You will oversee sterile injectable product release, QA operations, and compliance with GMP and regulatory standards, ensuring inspection readiness and a strong quality culture on site.

Applicants should have 5+ years in pharma QA, a degree in pharmacy/chemistry/biology, and fluency in Spanish and English. The role supports cross-functional collaboration, ongoing improvements, and staff development in a

Qualifications

• Minimum 5+ years in the pharmaceutical industry with QA Operations experience.
• Strong knowledge of cGMP regulations and regulatory standards.
• Solid understanding of aseptic processes and aseptic manufacturing practices.
• Excellent organizational skills, attention to detail, and teamwork.
• Fluent in Spanish and English, both written and spoken.

Responsibilities

• Lead implementation and continuous improvement of QA compliance across site.
• Oversee QA Operations activities including product release and documentation management.
• Ensure quality oversight of manufacturing operations and qualification activities.
• Manage quality processes: OOS/OOT/OOE, deviations, CAPA, complaints and recalls.
• Escalate quality/cGMP issues and communicate with stakeholders and authorities when required.
• Support audits, inspections, and annual quality reviews.
• Monitor quality performance and drive improvements with site leadership.

Skills

QA Leadership

GMP Compliance

Regulatory Knowledge

Attention to Detail

Team Management

Education

Science degree in Pharmacy, Chemistry, or Biology

Job description

Job Description Summary

Salary Range: €45,100.00 - €83,700.00 Job Description Summary #LI-Onsite

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, 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 Biology 5+ 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 and spoken.

Desirable Requirements

• Previous Experience as a certified Qualified Person is highly valued.

Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. The rewards of being part of our team go far beyond base pay and incentives.We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave. Expected Annual Base Salary Range for role: Spain: EUR 45,100 – 83,700 The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process. Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics. Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Commitment to Diversity and Inclusion / EEO paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Skills Desired

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.