Quality Engineering Manager

The QEV Manager is responsible for the implementation and management of the Engineering Quality Assurance and Qualification department.

In this role, you will be required to:

• Lead the Quality Assurance process for capital projects and upgrades of existing facilities, including GMP infrastructures (controlled environments/cleanrooms, clean utilities production, and gas distribution systems) as well as production and analytical equipment
• Oversee Quality Assurance processes related to qualification and validation activities, including computerized system validation (CSV), in compliance with EU GMP Parts I and II, as well as Annexes 11 and 15
• Act as the key point of contact for Technical Services and IT regarding deviation investigations, CAPA implementation, and Change Control support

As part of the integration into the Sandoz group, you will also manage the transition of QEV-related quality systems to Sandoz standards.

You will also be responsible for:

• Managing a team of approximately ten employees (permanent staff and consultants)
• Managing the department budget and organizing team activities
• Maintaining procedures up to date and ensuring compliance with evolving regulatory requirements within your scope
• Monitoring quality performance metrics and contributing to Management Reviews in collaboration with the Head of Quality Systems
• Reporting on your scope of responsibility to your direct manager

You may also be required to represent your area during client audits and regulatory inspections and to contribute to their preparation and coordination.

Qualifications

Master’s degree (Engineering degree / Pharmacist) or equivalent, with a specialization in Pharmaceutical Quality Assurance and/or a minimum of 7 years of experience, primarily in qualification/validation environments. Previous team management experience is required.

Technical Skills (Hard Skills)

• Strong knowledge of Good Manufacturing Practices (EU GMP Parts I & II), with particular expertise in Annexes 1, 11, and 15
• Knowledge of US FDA regulations is a plus
• Training and/or experience in bioproduction is an asset

Soft Skills

• Strong interpersonal and communication skills
• Team-oriented mindset and active listening abilities
• Proactive attitude and appetite for challenges and new topics

Profile

• Excellent analytical, organizational, and synthesis skills
• High adaptability and autonomy

Languages

Fluent English (written and spoken) is required.