Quality Assurance Compliance Lead

• 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.

:

• 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

• 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.

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 Note: 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.