QA Operations Expert

About the role

As a QA Operations Expert you will support the introduction of new autoinjector devices into the commercial phase and manage primary packaging and device suppliers from a quality perspective. You will ensure compliance with cGMP, regulatory requirements and Novartis quality standards.

Key responsibilities

• Manage third‑party device component and primary packaging material suppliers.
• Evaluate and implement changes related to assigned materials.
• Oversee incoming testing activities, ensuring cGxP compliance, data integrity and e‑Compliance.
• Review and approve production, QC and AS&T records.
• Support exception investigations and review DHF/DMR documents for commercial medical devices.
• Report technical complaints, adverse events or special cases within 24 hours.
• Participate in OpEx improvement projects.

Required profile

• University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent.
• Minimum 3 years experience in MS&T, QC, QA or the medical‑device industry.
• Experience in operations or third‑party supplier management.
• Fluent written and spoken English; German is a plus.
• Ability to work in a fast‑paced, changing environment.

Required skills

• cGxP and GMP knowledge
• Data integrity management
• Quality Management Systems (QMS)
• Statistical Process Control (SPC)
• Supplier Quality Management
• Regulatory compliance

What we offer

• Market‑competitive base salary with performance‑based bonus potential.
• Attractive incentive program and modern pension scheme.
• Childcare facilities, learning and development opportunities.
• Worldwide career possibilities within the Novartis group.