- Take ownership of the quality batch release system, ensuring its effectiveness, efficiency, and compliance with regulatory requirements.
- Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and reliability of the batch release system. Identify areas for optimization and implement best practices to streamline operations.
- Identify and mitigate risks associated with batch release activities, ensuring that potential quality issues are addressed proactively to minimize impact on product quality and compliance.
- Collaborate with cross-functional teams, including Manufacturing, Quality Control, Regulatory Affairs, and Supply Chain, to ensure seamless coordination and communication throughout the batch release process.
- Lead, facilitate and support quality process work streams related to Batch Release involving cross-functional, cross-divisional experts with specific knowledge from countries, manufacturing sites and impacted functions, to deliver a lean, agile & scalable business process.
- Represent Quality Assurance ("QA") business team in different project streams with different teams inside QA organization and with other functions.
- Explore and utilize technology solutions to simplify, optimize, digitize, and automate business Batch Release process through close collaboration with Quality Innovation team and via external bench-marking.
- Ensure consistent performance and implementation of Batch Release HUB application throughout the organization.
- Manage and Coordinate all OpEx initiatives related to the Operation Hubs interacting with RE NCQ Hubs in alignment with the local Management, RE Hubs Operational Lead and with the Global NCQ OpEx Head
- Minimum of 10 years of experience in quality assurance, quality control, or regulatory affairs within the pharmaceutical or biotechnology industry.
- Experience with batch record review, deviation management, and regulatory inspections preferred.
- Management of successful OpEx Projects
- Good knowledge and Mastering of Batch Release Hub tool
- Excellent communication, presentation, leadership, stakeholder management and problem-solving skills.
- Overall understanding of technologies used in the product.
- Project management skills and ability to work effectively in a fast-paced, dynamic environment with competing priorities
- Fluency in English as a business language (oral and written)
Operations Manager - España - Novartis Farmacéutica
Descripción
Operations Manager & Batch Release Hub Tool Product Owner
Job ID REQ
Apr 16, 2024
Spain
About the Role Job Description Summary
The Operations Manager & Batch Release Hub Tool Product Owner is ensuring that all processes and procedures, tasks, responsibilities, product road-map, and projects linked to Batch Release Hub tool are in compliance with all pharmaceutical laws, the Novartis Quality Manual and Policies as well as Industry Best Practices. This role comprises special GxP requirements and must be executed in accordance with these. In this role, you will also ensure that all quality relevant processes are compliant and preventive actions (CAPA) and/or escalation of issues are taken care and you will be responsible for management, coordination, design, implementation and/or completion of Operations projects in Hubs and across Region Europe.
Major accountabilities:
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Division Operations
Business Unit Pharmaceuticals
Location Spain
Site Barcelona Gran Vía
Company / Legal Entity ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.
Functional Area Quality
Job Type Full time
Employment Type Regular
Shift Work No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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