Remarkable developements occur at Sandoz due to the combination of individual characteristics, personal interests and professional qualification. This is why we are seeking employees with a passion for all that they do and who will work together with us to achieve the common goal: to provide patients in Austria and all over the world with high-quality, affordable pharmaceutical products. We, Sandoz, are one of the largest pharmaceutical companies in Austria with over 4.000 employees at four sites. As a member of the global Novartis Group, we develop, produce and market generic pharmaceuticals – above all antibiotics, injectable cancer drugs and innovative biosimilars. Come and work with us as …
Site Data Integrity Lead (m/f)
Quality Unit, Novartis Technical Operations, Kundl
Area of Responsibility
- Strengthen a culture of Data Integrity Excellence and assure appropriate systems and processes to support GMP data integrity.
- Drive, monitor and assure delivery of the site DI Plan, including DI communication and engagement plan.
- Setup and maintain a site network of functional DI Subject Matter Experts (SME)/ DI Champions within appropriate GMP functional areas (e.g. Manufacturing, Maintenance, MS&T, Engineering, QA Ops, QC, etc.)
- Continuously improve data integrity knowledge base and understanding: Identify training needs, and ensure availability of appropriate and functionally relevant training materials
- Participate in design and delivery of activities to engage shop floor employees in strengthening quality culture
- Drive sustainable improvement in detecting and mitigating DI risk by working with SMEs to embed DI focus in existing site programs, for example, self-inspection program, continuous improvement program, Gemba walks, etc.
- Support preparation for regulatory / health authority inspections and/or response development for DI related topics
- Facilitate the identification of high-risk data processes and systems
- Ensure site support for DI topics in escalations, investigations, rapid alerts, reviews and audits related to Data Integrity for both internal Novartis and external parties.
- Education: University degree in Life Sciences (preferred Biology, Pharmacy, Chemistry)
- Languages: Fluent in English and German (written & spoken)
- Experience: minimum of 5 years of working experience in Quality Assurance or in manufacturing areas within the pharmaceutical industry, experience with data integrity, risk management or compliance topics are essential. Excellent program/project management skills are required. Result and action orientation, strong communication skills, good skills in identifying issues and solving problems strengthen your profile.
Our salary packages are competitive and take individual qualifications and experience into consideration. Moreover we offer attractive fringe benefits (e.g. profit sharing for all employees, modern company pension, childcare facility, training possibilities and global career opportunities). In accordance with the Austrian collective labour agreement, we advise you that the minimum gross annual salary for this role is 57.321,74 euros.
Please apply online under the following link: Online Application (Job ID 220658BR)
Contact: Cornelia Walch, Staffing Manager
Sandoz is an equal opportunity employer