QA Manager

Your responsibilities are:

·       Develop, implement and maintain robust quality assurance processes and systems to meet regulatory requirements, such as Good Manufacturing Practices (GMP).

·       Lead the Quality operations team. Hire, coach and appraise employees, and develop employees using the relevant HR instruments, service and procedures. 

·       Working with the production department to ensure that all production activities are in line with quality standards. Develops and optimizes a quality assurance system in consultation with the various actors and process managers with a focus on the operational quality systems like Deviations, CAPA etc. 

·       Ensure compliance with regulatory requirements, such as FDA regulations, guidelines, and other applicable standards. 

·       Coordinate and support regulatory inspections and audits, and respond to any findings or observations in a timely manner. 

·       Implement and manage an effective deviation management and corrective action/preventive action (CAPA) program. 

·       Keeps an eye on developments at national and international level with regard to the governance and regulation of the pharmaceutical sector.  

·       Timely execution of Batch record review and approval, batch releases and quality records review and approval. 

·       Translates annual departmental business objectives to the team and makes sure the objectives are met. Organizes the activities and tasks of the team. 

·       Has a broad and in depth understanding of existing and emerging regulatory GxP requirements within own field of expertise. Decision maker with regards to GxP (e.g. decisions on deviation impact). Manages or gives advice on SOPs, GxP deviations and change control and follows mandatory GxP training and maintains an appropriate training record.  

Your Profile

·       Bachelor Degree in Life Sciences, Chemistry, Pharmacy or comparable.

·       Extensive experience in the pharmaceutical environment.

·       Experience in either pharmaceutical production or quality management.

·       Strong leadership and team management abilities and experience, with a focus on mentorship, development, and fostering a culture of quality and compliance. 

·       Continuous Improvement (CI) experience is preferred (e.g Green Belt or Black Belt or comparable).

·       Strong analytical and problem-solving skills, with the ability to make informed decisions based on data and risk assessment. 

·       Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams and communicate complex quality concepts to stakeholders at all levels. 

·       Detail-oriented mindset and ability to work in a fast-paced, highly regulated environment. 

Our Offer

We offer you a full-time job and a one-year contract to begin with. The following employment conditions apply:

·       Full-time employment

·       8.33% end of year bonus and 8.33% holiday allowance

·       Flexible working hours in consultation

·       Personal training budget of €2,000 per 3 years

·       Contribution to travel expenses from the first kilometer

·       Good accessibility by public transport and private parking

·       Pension plan at Zorg & Welzijn.

Learn More

If you want to know more about this vacancy, please contact our recruitment department via careers.nl@prothya.com. Do you recognize yourself in the profile and do you want to take on this challenge at Prothya Biosolutions? Then we would like to receive your CV and motivation via the apply button on this page. We aim to give you a response back within a week.

Acquisition is not appreciated. Prothya does not accept unsolicited help from agencies for this vacancy. Resumes (in whatever form) sent by recruitment agencies to any employee of Prothya without a valid written request are considered to be the property of Prothya for which no compensation is due in any way.