Site Quality Head

Deadline for applications: 7th of September, 2026.

Major Accountabilities:

• Lead the site Quality organization and ensure an effective, independent Quality function supporting manufacturing and packaging operations across solid dosage, ophthalmic, and aseptic products.
• Establish, maintain, and continuously improve the Quality Management System, ensuring compliance with cGMP, regulatory requirements, corporate standards, ISO 9001, and local legal obligations.
• Ensure regulatory compliance and inspection readiness, including health authority registrations, internal and external audits, regulatory inspections, Site Master File maintenance, and strong relationships with authorities.
• Ensure product quality and batch release by verifying that products are manufactured, tested, reviewed, and released in compliance with registrations, specifications, GMP requirements, and quality standards.
• Oversee quality systems and risk management, including deviations, OOS/OOX, complaints, CAPA, recalls, quality gap assessments, KQIs, incident escalation, and proactive continuous improvement.
• Provide GxP oversight for manufacturing, control, distribution, data integrity, eCompliance, change management, qualification, validation, equipment, facilities, utilities, suppliers, stability, and contract analysis activities.
• Build and develop a high-performing Quality team through recruitment, training, coaching, performance management, succession planning, talent development, GMP qualification, and employee engagement.
• Promote safety, quality culture, business continuity, and crisis management readiness, while supporting HSE incident reporting, action follow-up, site leadership responsibilities, and acting as Site Head deputy when required.

Obligatory Requirements:

• University degree in Pharmacy, Engineering, Chemistry, Biotechnology, or an equivalent relevant discipline.
• 10+ years of experience in Quality Assurance, Quality Control, and/or pharmaceutical manufacturing within a multinational pharmaceutical environment, ideally in solid dosage forms manufacturing and packaging.
• Strong experience with regulatory inspections, QC laboratories, GMP QC testing, GxP operations, manufacturing processes, and product expertise.
• Proven ability to manage teams, including 5+ direct reports, with strong people leadership, motivation skills, and the ability to set clear expectations.
• Solid understanding of regulatory environments, with the capability to engage effectively with Romanian Health Authorities and FDA.
• Strong operational capability, including the ability to balance demand and capacity, manage priorities, meet timelines, and react quickly to issues.
• Demonstrated strengths in structure, diligence, collaboration, stakeholder engagement, risk management, decision-making, and proactive problem-solving.
• Fluent in Romanian and English, both oral and written.

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: 

• Romania: RON 291,480 – 541,320 

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.  

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