QA Operations Manager & QP

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.