Quality Assurance Manager (f/m/d) ESO
|Division||Novartis Technical Operations|
|Art der Stelle||Vollzeit|
• Lead External Suppliers Qualification process
• Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier
• Ensure that all aspects of the handling, manufacturing and distribution of products are in compliance with the Novartis Pharma Quality Manual, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs
• Responsible for driving / initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. If gaps are identified, remediation plans are to be defined to ensure that issues are suitably addressed
• Provide the quality presence and in-put to Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and Goals
• Ensure that a valid QA agreement defined in line with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between Novartis and the External Supplier, as well as product details and requirements
• Signs QA agreements if assigned by QA Lead
• Request, review and process GMP documentation as defined by the Quality Agreement and Novartis SOPs
• Manage the quality aspects of the relationship in accordance with the effective Quality Agreement
• Makes recommendations for amendments to the agreement based on identified needs and issues
• Responsible for coordinating and ensuring that Quality auditing of external suppliers is carried out according to the Novartis Quality Manual
• Ensures action plans are in place and follow up on agreed on CAPAs is performed
• Supports site readiness for regulatory inspections at external suppliers where appropriate
• Manages all critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Agreement and the Novartis Quality Manual
• Ensures investigations are correctly executed
• Ensures an oversight of change requests, either from the External Supplier or from Novartis is maintained and changes are managed according to the Quality Agreement and Novartis SOPs from receipt, through to the implementation and closure
• Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance .
• Stability reports and PQR’s. Ensures together with support group, that the External Supplier provides the required product review or the data as specified in the relevant Quality Agreement on an annual Basis
• Participates in critically assesses the performance of the product and process and after delegation by QA Lead signs the PQR and provides the executive summar/assessment to the report
• Escalates any issues per the Novartis escalation policy, and initiates any market action that is required
What you’ll bring to the role:
• Bachelor or higher in Biochemistry, Chemistry, Microbiology or another related science
• 5-8 years experience in the pharmaceutical / device industry
• Experience in QA operations, production, QC and/or other relevant operational areas, but must include min. of 2 years in QA, 2 years of management and or project management experience or equivalent
• Thorough knowledge of cGMP requirements
• Solid understanding of regulatory requirements for commercial products
• Proven track record with inspections from Health Authorities is preferred
• Strong understanding of risk assessment and risk management fundamentals/tools
• Technical understanding of pharmaceutical processes
• Team and consensus builder, with definitive and authoritative decision-making ability
• Fluent in English, German is desired
An open corporate culture, interesting and challenging tasks, attractive social benefits as well as opportunities for individual career growth within an international company.
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.
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