Head QA Operations (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 QA Operations (m/f/d)
•Being accountable for leading the cross-divisional German QA operations team and for managing the day-to-day activities of the QA Operations department
•Actively support the German Quality department through interface and collaboration with all levels of Global QA units and local business organizations
•Support cross-divisional standardization and efficiency gains through innovation and operational excellence projects
•Prevent quality or regulatory non-compliance issues which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the financial performance of the company, as well as the company reputation
•Ensure that applicable KQIs for the QA Operations Team (including the Commercial EU Release Hub) meet expectations and that non-compliances are addressed via corrective and preventive actions
•Responsible to ensure that commercial products for Germany and EU-countries are released in full compliance with regulatory requirements and in accordance to the business needs
•Ensure that a process is in place that ensures the timely review of Product Quality Reviews for products that are managed under the MIA, the GDP license or for which Novartis Pharma GmbH, Hexal AG or 1A Pharma is Marketing Authorization Holder
•Responsible for critical issue of any significant quality issues through the appropriate internal blocking issue channels and to manage associated Health Authority interactions
•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
•Support the generation of the AQMR and provide support to achieve other Quality objectives as defined in Quality Plan
•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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