Manager Quality Assurance (m/f/d) - Nürnberg
|Division||Novartis Technical Operations|
|Art der Stelle||Teilzeit|
3! That is the number of Novartis businesses in Germany you will be working with through one single, integrated quality management system.
As a Manager for Quality Assurance, you will support the implementation of the Quality Management System through establishment, maintenance and continuous improvement of processes in full adherence to all applicable national and international GxP-regulations and with Novartis corporate Quality Manual. Actively support the German Quality System through interface and collaboration with all levels of Global QA units, local business organizations and Health Authorities.
Your daily tasks:
• Quality Management System - Support implementation of Novartis corporate Quality Manual and Policies and act as interface to the global Quality organizations
• Quality Management System - Ensure that all parts of the local GxP-Quality Management System (SOP, WPs etc) are continuously improving to always comply with internal and external requirements/expectations. In particular, ensure that QMS complies with national regulatory requirements (e.g. AMG, AMWHV, AmHandelsV)
• QA Business Partner – Provide QA support to ensure successful launches and day-to day activities (e.g. Deviations, Change Control)
• Reporting – Support tracking and follow-up on Key Quality Indicators
• HA - Liaison – Manage official Health Authorities requests (e.g. related to FMD alerts / complaints)
• Audit- and Inspection Management - Represent the organization in GDP- and GMP- regulatory inspections and internal audits
• Project Management – Act as a senior project manager within the quality department (e.g. IT system implementation)
What you will bring to the role:
• Master Degree or equivalent 4-Year University degree in a Scientific or Technology field (e.g. Pharmacy)
• Fluency in German and English (oral and written)
• Five years` experience in pharmaceutical industry, with a minimum of 2 years in Quality Assurance, preferably in Quality Systems
• Senior expert understanding of GxP regulations in Germany and EU and solid understanding of Health Authority expectations and industry trends
• Ability to build trusting relationships with senior management, other business stakeholders and Health Authorities
• Demonstrated ability in initiating and delivering high impact projects
• Excellent communication, negotiation, consulting/facilitation, and interpersonal skills
Why consider Novartis?
750 million. That’s how many lives our products touched in 2018. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks. And where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help reimagine medicine.
We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.
Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
We are looking forward to receiving your detailed application at: www.karriere.novartis.de
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