Quality Assurance Operations Lead

Novartis Italia; Ivrea; In loco; EUR 58.000 - 108.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid working options

14 weeks paid parental leave

Insurance plans

Retirement plans

Descrizione del lavoro

Novartis Italia in Ivrea, Italy is seeking a Quality Assurance Operations Lead to ensure released products meet GMP, FDA, and regulatory standards and to provide QA oversight of manufacturing activities. You will lead QA Operations, manage resources, approve quality processes, support audits, and drive continuous improvement across the site.

The role requires a scientific degree and 5+ years in pharma QA, fluency in Italian and English, and offers hybrid work, competitive benefits, and a salary

Competenze

• 5+ years in the pharmaceutical industry with QA Operations experience.
• Strong knowledge of cGMP regulations and quality standards.
• Experience with aseptic manufacturing processes.
• Excellent organizational skills and attention to detail.
• Strong communication and collaboration abilities; ability to work with urgency.
• Fluent in Italian and English (written and spoken).

Mansioni

• Lead implementation and continuous improvement of quality standards compliance.
• Oversee QA Operations activities: product release, documentation, SOPs, training, resource planning, shift organization for QPs and QA Officers.
• Ensure QA oversight of manufacturing operations, qualification, calibration, revalidation, process validation, cleaning validation, equipment qualification, and new projects requiring QA Operations support.
• Manage and approve quality processes: OOS, OOT, OOE, deviations, change controls, CAPA, complaints, recalls, investigations.
• Ensure timely escalation and communication of quality and cGMP issues to stakeholders and authorities when required.
• Support audits, inspections, and quality reviews by participating in audits and annual reviews.
• Monitor quality performance and drive improvements with Site Management, Quality, Quality Control, and Production leaders.
• Provide QA support to commercial operations with environmental, safety, order, cleanliness, internal communication, and external communication requirements.

Conoscenze

QA Operations

cGMP knowledge

Aseptic processing

Organizational skills

Communication & collaboration

English & Italian fluency

Formazione

Degree in Pharmacy, Chemistry or Biology

Descrizione del lavoro

Summary

Location: Colleretto Giacosa (Ivrea), Italy

This role is based in Ivrea, Italy. 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 is responsible for ensuring the release of products manufactured in compliance with the Quality System, current registrations, and applicable regulatory standards. This includes guaranteeing that sterile injectable products meet GMP, FDA, AIFA, Novartis Quality Manual, and other relevant quality requirements, while ensuring site operations remain fully compliant.

The position provides quality oversight of manufacturing activities, manages the human and technical resources of the Quality Assurance Operations department, and ensures effective QA support for the site’s commercial operations.

About The Role

Deadline for applications: 18th of September 2026.

Major Accountabilities

• Lead the implementation and continuous improvement of compliance with applicable quality standards, including GMP, FDA, AIFA, 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 Italian and English, both written and spoken.

Desirable Requirements

• Experience in a high-tech production environment as a 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: EUR 57,900.00 - 107,500.00 EUR

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

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

Learn about all the ways we’ll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)