Summary
About the Role
Major accountabilities:
- Lead the Site Quality organization, ensuring quality oversight of all GxP functions and acting as the site Technical Responsible Person (Qualified Person).
- Ensure product quality, regulatory compliance, and implementation of corporate quality standards, including maintenance of local HA registrations and preparation of the Site Master File.
- Govern and comply with the Novartis Manufacturing Manual, manage site quality risk assessments, and conduct Quality Management Reviews.
- Approve or reject raw materials, facilities, utilities, intermediates, finished products, stability samples, and PQR/APQR, while overseeing exception and complaint management.
- Ensure effective training execution, data integrity, eCompliance, and adherence to all cGxP, HSE guidelines, and local legal requirements, including business continuity management and collaboration with 3rd parties under appropriate Quality Agreements.
- Drive the talent agenda by recruiting, training, coaching, developing succession plans, promoting talent exchange, and fostering a high-engagement culture aligned with Curious, Inspired, and Un-bossed behaviors.
- Promote and improve Safety and Quality cultures, ensure inspection readiness, support crisis management and Business Continuity Plans, and oversee HSE incident reporting and follow-up.
- Ensure the quality management system conforms to ISO 9001, that processes deliver intended outputs, report performance and improvement opportunities to top management, promote customer focus, and maintain QMS integrity during changes.
Obligatory requirements:
- Education : University degree in Pharmacy, Engineering, Chemistry, Biotechnology or equivalent.
- 12-15 years’ experience in the field of Quality Assurance and Quality Control in a pharmaceutical industry environment or equivalent.
- Strong technical knowledge in Drug Substance Manufacturing Operations Management and Execution.
- Solid stakeholder management - especially with labor unions and Health authorities.
- Knowledge of GMP Quality Control (QC) Testing, Manufacturing Process/Product Expertise.
- Fluent English and French (oral and written).
Desirable Requirements:
- Additional specialist experience in QC is preferred.
You’ll receive:
- Annual bonus
- Focus on career development
- Quality of Work Life approach allowing you to propose improvements for your daily life
- Emphasis on work-life balance with arrangements such as telecommuting, reduced annual working hours, or parental leave
- Advanced social coverage for you and your loved ones
- 27 paid vacation days and at least 14 JDR (days off) days per year
- Various employee recognition programs
Commitment to Diversity and Inclusion / EEO:
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
