QA Operations Manager & QP

Job Description Summary

The Quality Operations Manager / QP provides oversight of Quality Operations across the site and assures that all batches are released according to registered specifications. The QA operations Manager provides leadership to the team of QA Specialists and Release Responsible Persons/QPs and also acts as the site’s Lead Qualified Person.

 

Job Description

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.

 

Skills Desired

Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Decision Making, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge