QA Operations Manager & QP
Summary
About the Role
Major Accountabilities:
- Provide oversight of Quality Operations across site, e.g. inbound and outbound QA oversight, MBR review and approval, product release, QA for QC and AS&T, Production (shop floor presence and collaboration), Engineering (oversight over maintenance, calibration), MS&T (validation activities, life cycle management), QA Operational Excellence.
- Provide leadership to the team of QA Specialists and Release Responsible Persons/QP.
- Define resource needs related to the QA operations team. Ensure the team members are open to development and define training needs.
- Assure that people are trained on time and track additional training needs. Provide input to training needs and assure that the site associates have appropriate GMP training.
- Lead batch release activities and QP certification of the batches.
- Review, define updates and, approve of all the site specific quality operations procedures.
- Provide input to the site master plan and quality plan of the site.
- Review and approval at site level of OOS/OOT, deviations and complaint.
- Support inspections by Health authorities and Novartis internal au dits. Assure that related CAPA’s are implemented on time.
- Ensure that all the variations to the Marketing Authorization are implemented at local level.
Essential Requirements:
- Master’s degree in scientific disciplines.
- +5 years of experience in a similar role within the pharmaceutical/biotech industry.
- Proven people management skills.
- Fluent in English.
- Demonstrate an agile mindset by setting clear priorities, collaborating openly, and using feedback to make step-by-step improvements – reflecting the core elements of Agile culture within the Dutch organization.
Desirable requirements:
- Fluent in Dutch.
- Experience in sterile manufacturing pharmaceutical environment.
- Own a QP certification or have the required technical background to obtain it.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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