Job Description

Location: Schaftenau, Austria #onsite

Role Purpose:
Provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards.
This person will manage projects, including Quality Plan initiatives, and processes that support quality objectives to assure their compliance with GxP regulations.

Major Accountabilities:

• Support maintenance of the regulatory -required files for health authority inspections and assist with health authority inspection management
• Support generation of Quality Plans (and review other plans for quality/safety aspects) for clinical programs
• Support initiatives to maintain or improve quality performance and compliance of operational activities including risk management, health authority reporting, IT systems
• Support initiatives focused on quality, process and compliance improvement, including identification of opportunities and develop strategies aimed at improving quality while ensuring compliance with regulatory requirements
• Ensure information gained during quality and compliance initiatives, as well as audit and assessment results, are evaluated to identify any regulatory, compliance and QA training needs
• Aid in the identification of quality issues and assist with root cause investigations and support the development of corrective and preventative action plans (CAPA), including monitoring status to Ensure issues are addressed, completed and documented.
• Provide assistance in the remediation of deviations, Ensure follow up and monitoring of associated corrective and preventive actions.
• Manage and Support quality aspects of projects and activities, including those related to third parties, analytical instruments, manufacturing equipment, quality plans, training, IT validations, etc.
• Review and approve quality deliverables to ensure compliance (including procedures, records, third party work, contractors, clinical trial material, components, gap assessments)

Key Performance Indicators:

• Clusters Quality System in place and continuously updated, as required risks proactively identified and effectively mitigated
• The number and severity issues identified during internal and external audits.
• Demonstrated/recognized leader of specific GxP; early external/industry engagement
• Sufficient financial knowledge (e.g., cost management, budget forecast, etc.)
• Role Model of Novartis culture, values & behaviours

Work Experience:

• Audit & Inspection Management
• Quality Management Systems
• Quality Assurance
• GxP Experience
• Good Manufacturing Practices (cGMP)
• Quality Compliance
• Good Laboratory Practice (GLP) Analytics
• Incident Management
• Deviation Management
• Corrective and Preventive Action (CAPA) Knowledge
• Third Party Management
• Change Control Management
• SOP (Standard Operation Procedure) Management

Languages:

• German is a must have
• English

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 us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is €65,605.54/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies

Skills Desired