About the role

Aplyr's Quick Take

This role is focused on ensuring compliance with Good Manufacturing Practices (GMP) in a sterile production environment. You'll be reviewing documentation, managing quality systems, and supporting audits and inspections. It's primarily an individual contributor role with some leadership responsibilities in quality governance.

Good fit

Ideal candidates have 2-3 years of experience in quality assurance within a pharmaceutical or biotech setting, particularly in sterile production. You should be detail-oriented, fluent in Italian and English, and comfortable with regulatory compliance.

Worth noting

The salary range is relatively broad, suggesting potential for negotiation based on experience. The role emphasizes both operational and strategic contributions, which may appeal to those looking to impact quality systems significantly.

Job Description Summary

Support GMP related activities—both operational and strategic—to ensure continuous compliance with applicable regulatory requirements, internal quality standards, and site procedures (SOPs). Actively contribute to the implementation, monitoring, and improvement of quality systems, providing expertise in GMP governance, risk management, and process oversight to maintain a robust state of control across all operations.

Job Description

Key responsibilities:

Drive technological and organizational improvements to enhance manufacturing quality, productivity, cost efficiency, and resource optimization.
Ensure full GMP compliance across operations, aligning site practices with company policies, standards, and regulatory requirements.
Support development and lifecycle management of new products, process improvements, and existing product enhancements.
Review and approve GMP documentation (e.g., batch records, specifications, protocols) ensuring accuracy, traceability, and compliance.
Oversee document lifecycle management (paper and electronic), ensuring proper control, data integrity, and archival.
Manage quality systems activities including deviations, CAPAs, Change Controls, complaints, and laboratory investigations (OOS/OOT/OOE).
Lead or support audits, inspections, self-inspections, training compliance, supplier qualification, and Site Master File/APQR preparation.
Contribute to continuous GMP governance and regulatory expertise development, supporting readiness for future QP responsibilities.

Essential requirements:

Scientific degree.
2/3+ experience in a similar role within a sterile production environment.
Good knowledge of GMP.
Fluent in Italian. Good knowledge of English.

Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

At Novartis we’re committed to reimagining medicine together – and rewarding the people who make it happen.

Expected annual Salary Base Range for the role: EUR 29.800,00 - 55.300,00

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

Commitment to Diversity and Inclusion:

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

Skills Desired

Continuous Learning, Good Documentation Practice, Guideline, Knowledge Of Capa, Managing Ambiguity, Qa (Quality Assurance), Quality Management, Regulation, Self-Awareness, Technical Knowledge

Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
Synthesized from recent postings & public sources

What's promising

•Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
•The company offers a wide range of global career opportunities across various fields.
•Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

•Regulatory challenges can impact the speed of drug approval and market entry.
•High competition in the pharmaceutical industry requires constant innovation to maintain market position.
•Complex organizational structure may slow decision-making processes.

Why Novartis

•Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
•The company emphasizes a diverse and inclusive workplace culture across its global operations.
•Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Novartis

Novartis

novartis.com

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Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.