QA Operations Lead – Medical Devices & Supplier Quality

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH; Österreich; Hybrid; EUR 60,000 - 74,000; Full time

Job summary

Novartis Pharmaceutical Manufacturing GmbH in Schaftenau (Hybrid) seeks aQuality professional to manage device component and packaging supplier quality. You will ensure cGMP compliance, approve records, and support investigations while driving OpEx improvements and supplier quality initiatives.

The role requires a university degree in a relevant field, 3+ years in MS&T/QC/QA or medical devices, and fluent English, with German desirable for cross-border collaboration.

Qualifications

• University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent.
• At least 3 years or more experience in MS&T, QC, QA or medical device industry.
• Experience in relevant operations or third party management.
• Fluent knowledge of English language (written and spoken).
• Flexibility to work in a fast paced, quickly changing work environment.

Responsibilities

• Responsible for third party management of device component and primary packaging material suppliers.
• Responsible for evaluation and implementation of changes related to assigned materials.
• Oversight of incoming testing activities, ensuring compliance with cGxP, incl. data integrity and eCompliance.
• Review and approve of production, QC, and AS&T records.
• Support exception investigations.
• Review and approval of DHF and DMR documents for Commercial medical devices and combination products.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Support OpEx improvement projects.

Skills

English language proficiency

German language (desirable)

Education

University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent

Job description

Novartis Pharmaceutical Manufacturing GmbH in Schaftenau (Hybrid) seeks aQuality professional to manage device component and packaging supplier quality. You will ensure cGMP compliance, approve records, and support investigations while driving OpEx improvements and supplier quality initiatives.

The role requires a university degree in a relevant field, 3+ years in MS&T/QC/QA or medical devices, and fluent English, with German desirable for cross-border collaboration.