Quality Assurance Compliance Lead

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

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

14 weeks parental leave

Job summary

Advanced Accelerator Applications Iberica S.L.U. in La Almunia de Doña Godina, Spain, seeks a QA Compliance Lead to ensure GMP-aligned quality systems, support inspections, supplier oversight, and continuous improvement across the site.

You will collaborate across teams to maintain inspection readiness, execute the Site Quality Plan, and manage data integrity and regulatory compliance. The ideal candidate has a life-sciences degree, 4+ years in pharma compliance, and fluency in Spanish and

Qualifications

• Bachelor’s degree or higher in Pharmacy, Biochemistry, Chemistry, Biology, Engineering or life sciences.
• At least four years of pharmaceutical industry experience with compliance and Quality Systems.
• Strong knowledge of GMP, GCP and Pharmacovigilance requirements.
• Fluent written and spoken Spanish and English, with strong communication and collaboration skills.

Responsibilities

• Ensure site Quality Systems comply with GMP regulations and Novartis quality standards.
• Lead inspection readiness and support regulatory inspections, audits and CAPAs.
• Plan and support Product Quality Reviews, self-inspections and Site Quality Plan.
• Oversee supplier quality activities, including QAAs and supplier audits.
• Coordinate Quality Management Reviews and monitor KPIs to drive improvement.
• Support qualification, validation, change control and quality documentation.
• Provide oversight of data integrity, electronic compliance and process quality assurance.
• Support quality escalations, product recalls, market withdrawals and other quality actions.

Skills

Quality Systems

Regulatory Compliance

Risk Management

Bilingual Spanish/English

Communication skills

Education

Life sciences degree

Job description

Salary Range

€45,100.00 - €83,700.00

Job Description Summary

What if your expertise in quality compliance could help protect patients while strengthening how medicines are made? As QA Compliance Lead, you will play an important role in maintaining a strong quality culture at our La Almunia site, helping ensure our systems and processes meet Good Manufacturing Practice and regulatory requirements. You will collaborate across teams to strengthen inspection readiness, quality systems, supplier oversight and continuous improvement, bringing your experience and judgement to quality decisions that matter. Join us and help build confidence in the processes behind the medicines that reach patients.

Location

La Almunia de Doña Godina (Zaragoza, Spain).

Relocation Support

Relocation Support: This role is based in La Almunia de Doña Godina, Spain. Novartis is unable to offer relocation support: please only apply if accessible.

Application Deadline

Deadline for applications: 29th October 2026.

Key Responsibilities

• Ensure site Quality Systems comply with Good Manufacturing Practice regulations and Novartis quality standards.
• Lead inspection readiness and support regulatory inspections, corporate audits and associated corrective and preventive actions.
• Plan and support Product Quality Reviews, self-inspections and execution of the Site Quality Plan.
• Oversee supplier quality activities, including Quality Assurance Agreements and supplier audits.
• Coordinate Quality Management Reviews and monitor Key Quality Indicators to drive continuous improvement.
• Support qualification, validation, change control and quality documentation activities across the site.
• Provide oversight of data integrity, electronic compliance and process quality assurance requirements.
• Support quality escalations, product recalls, market withdrawals, returns and other commercial product quality actions.

Essential Requirements

• Bachelor’s degree or higher in Pharmacy, Biochemistry, Chemistry, Biology, Engineering or a related life science discipline.
• At least four years of pharmaceutical industry experience, with direct exposure to compliance and Quality Systems.
• Strong knowledge of Good Manufacturing Practice, Good Clinical Practice and Pharmacovigilance requirements.
• Solid understanding of regulatory Quality Systems requirements within a pharmaceutical environment.
• Strong knowledge of risk assessment and risk management principles and tools.
• Fluent written and spoken Spanish and English, with strong communication and collaboration skills.

Desirable Requirements

• Experience in a high-tech production environment as a certified Qualified Person.

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.

Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

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 Statement

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.

Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable.

A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

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

Collaboration, Communication, Continuous Improvement, Data Integrity, Decision Making, Good Manufacturing Practices (GMP), Leadership, Managing Ambiguity, Operational Excellence, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Inspections, Quality Management Systems (QMS), Regulatory Compliance, Statistical Process Control (SPC), Supplier Quality Management

China Cross-Border Data Transfer Policy

In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov.