Quality Manager Pilot Plant

Schaftenau, Österreich

Job ID: REQ-10075309

Location: Schaftenau, Austria #onsite

Summary

Role Purpose: The Quality Manager Pilot Plant is responsible for managing all the quality and compliance activities within the Development GDPD (Global Device and Packaging Department) Pilot Plant Schaftenau AT which performs assembly of drug device combination products and GMP testing. Routine tasks focus on QA oversight of manufacturing, batch record review, failure investigations and deviation, change controls, and release activities. Ensure that compliance with cGMP/ GxP is maintained in TRD (Technical Research and Development).

About the Role

Major Accountabilities

• Quality oversight of all GxP activities at the GDPD Pilot Plant, ensuring product quality and compliance with Novartis Quality standards.
• Ensure regulatory compliance to ISO 13485, 21 CFR 820, including health authority registrations and qualified state of facilities and utilities.
• Manage deviations, OOX, complaints, investigations, and CAPAs.
• Ensure Data Integrity and compliance with GxP, regulatory, and HSE requirements.
• Support internal and external audits.
• Support transfer projects and qualification activities.
• Participation in the compilation, revision and approval of validations, transfers, SOPs and other GxP related documents as applicable.

Minimum Requirements

• Minimum Bachelor’s with more than 5 years’ pharma quality or operations experience or Master’s degree with more than 3 years’ pharma quality or operations experience in Pharmaceutical Sciences, Biotechnology, Engineering, or a related field.
• Experience with drug device combination products, ISO 13485, 21 CFR 820.
• Good knowledge of cGMP, working knowledge in technical development, production or QA.
• Sound scientific, technical and regulatory knowledge.
• Strong organizational and decision-making skills.
• Strong ability to analyze and evaluate cGMP compliance.
• Knowledge of GxP requirements as well as experience with inspections.
• Flexibility to work in a fast-paced, quickly changing work environment.
• Knowledge of Manufacturing Process and Product Expertise.

Required Language Skills: Fluent English and German required, oral and written.

Skills Desired: Communication Skills, Continuous Improvement mindset, Data integrity, Dealing with Ambiguity, Digital savviness, leadership, Problem Solving Skills, Regulatory Requirements knowledge, Collaboration.

Adjustments for Applicants with Disabilities

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let Novartis know the nature of your request as well as your contact information.

Salary

In accordance with Austrian law, the minimum salary for this position is €65,605.54 per year on a full time basis. In most cases, the actual salary will be higher, as Novartis strives to maintain a competitive position in the market and considers previous experience, qualifications and individual competencies.

Why Novartis?

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people collaborating, supporting and inspiring each other to achieve breakthroughs that change patients’ lives.