Head Quality Management System (m/f/d)
|Geschäftseinheit||COMMERCIAL OPS EUROPE SZ|
|Standort||Holzkirchen (near Munich)|
|Art der Stelle||Vollzeit|
3! This is the number of Novartis companies in Germany that are subject to the quality management system!
For our x-divisional Country QA organisation in Germany we are currently looking for the new
Head Quality Management System (m/f/d)
•Drive the implementation of the Quality Management System through establishment, maintenance and continuous improvement of German business processes in full adherence to all applicable national and international GxP-regulations and with Novartis corporate Quality Manual
•Lead the cross-divisional German QMS team and ensure that a state of the art Quality Management System is in place to best support overall business strategy and support the German Quality System through interface and collaboration with all levels of Global QA units and local business organizations
•Provide Quality oversight and governance and engage business partners outside of QA to ensure that compliance objectives are met
•Ensure that all parts of the local GxP-Quality Management System (SOP, WPs etc.) are continuously improving to always align with internal and external requirements/expectations. In particular ensure that QMS aligns with national regulatory requirements (e.g. AMG, AMWHV)
•Lead the implementation of Novartis corporate Quality Manual and Policies and act as interface to the global Quality organizations
•Ensure that Quality Assurance Agreements with all local GxP-relevant vendors and suppliers are established and regularly reviewed
•Ensure timely delivery of all quality services, and ensure all aspects of team activities align with cGMP, legal, regulatory requirements and Novartis Pharma corporate Quality Manual and Policies
•Establish an effective Deviation, Change Control, Self inspection and Quality Risk Assessment process for all GxP-relevant activities in the German Country Organization
•Provide regular review and assessment of KQIs at the Germany Quality Committee and Executive Committees
•Represent the organization in GDP- and GMP- regulatory inspections, internal audits and pharmaceutical associations
What you’ll bring to the role:
•Master Degree or equivalent 4-Year University degree in a Scientific or Technology field (e.g. Pharmacy)
•Qualification as a “Qualified Person” according to §15 Germany Drug Law is considered beneficial
•Five to 10 years` experience in pharmaceutical industry, with a minimum of 5 years in Quality Assurance, preferably in Quality Operations paired with five or more years of demonstrated leadership and accomplishment in pharmaceutical industry
•Demonstrated ability to lead a diverse team and to initiate and drive organizational change in complex matrix environment
•Senior expert understanding of GxP regulations in Germany and EU and solid understanding of Health Authority expectations and industry trends
•Demonstrated ability to build trusting relationships with senior management, other business partners and Health Authorities/regulatory bodies
•Excellent communication, negotiation, consulting/facilitation, and interpersonal skills paired with fluency in Germany and English (oral and written)
•Excellent organizational awareness and demonstrated track-record of creating an inclusive, high performing culture which values and rewards the Novartis Values and Behaviors
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Join us, and help reimagine access to medicine.
Sandoz 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.
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