Application Manager QMS

Bilthoven Biologicals; Bilthoven; On-site; EUR 44,483 - 68,020; Full time

Benefits offered by this job

End-of-year bonus (13th month)

Good pension scheme

Dynamic work environment

Job summary

A biopharmaceutical manufacturing company is seeking an Application Manager QMS to optimize its QA platform. You will manage the functional and technical aspects of the QA application, ensuring compliance with pharmaceutical regulations. Responsibilities include translating business requirements into solutions and maintaining documentation. The ideal candidate holds a relevant bachelor’s degree and has strong analytical skills. Salary ranges from €3,986 - €6,095 gross monthly, with opportunities for growth in a dynamic environment.

Qualifications

• Strong analytical skills and ability to translate business needs into IT solutions.
• Relevant expertise in application management and change management.
• Preferably good knowledge of GxP/GAMP5 and experience with system validation.

Responsibilities

• Translating business requirements into functional and technical solutions within Veeva.
• Actively contributing to implementations, upgrades, and integrations with other systems.
• Ensuring compliance with relevant regulations (e.g., GxP/GMP, validation requirements).
• Analyzing incidents and performing necessary activities for and resulting from periodic reviews.
• Preparing and maintaining documentation (SOPs, work instructions, validation reports).
• Serving as a point of contact and sparring partner for internal stakeholders.

Skills

Analytical skills

Translation of business needs into IT solutions

Application management expertise

Change management experience

Knowledge of GxP/GAMP5

Communication skills in English

Communication skills in Dutch

Education

Bachelor’s degree in Computer Science, Business IT & Management, Pharmacy, or Life Sciences

Tools

Veeva

Job description

Application Manager QMS

As an Application Manager QMS, you play a key role in optimizing and managing BBio’s QA platform within the pharmaceutical environment. You are responsible for the functional and technical management, further development, and ensuring compliance of the QA application as an important system in our organization. With your knowledge of application management preferably QA systems and again preferably within pharmaceutical regulations (GxP, GMP), you ensure that BBio’s processes are efficiently, safe, and future‑proof designed. The QMS software used by BBio is Veeva.

Main tasks and responsibilities

• Translating business requirements into functional and technical solutions within Veeva.
• Actively contributing to implementations, upgrades, and integrations with other systems.
• Ensuring compliance with relevant regulations (e.g., GxP/GMP, validation requirements).
• Analyzing incidents and performing necessary activities for and resulting from periodic reviews of the application, in accordance with GxP/GAMP5/ISO guidelines.
• Preparing and maintaining documentation (SOPs, work instructions, validation reports).
• Serving as a point of contact and sparring partner for internal stakeholders such as QA, Regulatory Affairs, and IT.

The Ideal Application Manager QMS

• Completed bachelor’s degree, preferably in Computer Science, Business IT & Management, Pharmacy, Life Sciences, or equivalent.
• Strong analytical skills and ability to translate business needs into IT solutions.
• Relevant expertise in application management and change management.
• Preferably relevant experience as an application specialist of a QMS, preferably in the pharmaceutical or life sciences sector.
• Preferably good knowledge of GxP/GAMP5 and experience with system validation.
• Excellent communication skills in English and preferably also in Dutch.

What Bilthoven Biologicals offers

• Salary in scale 9 or 10 (between €3,986 - €6,095 gross per month, based on 40 hours per week) depending on your knowledge and experience.
• An end‑of‑year bonus (13th month) and a good pension scheme.
• A contract for 32 to 40 hours per week.
• A dynamic, socially driven work environment.
• A declaration of conduct (VOG) is part of this application procedure.

And most importantly: BBio is a growing company. This offers opportunities for ambitious people. Don’t expect a bed of roses, but do expect the chance to grow with BBio.

Job Vacancy at Bilthoven Biologicals

Bilthoven Biologicals (BBio) is an international biopharmaceutical manufacturing company. With approximately 500 colleagues, BBio produces vaccines such as polio, diphtheria‑tetanus‑polio (DTP), and BCG. BBio supplies vaccines to organizations including the World Health Organization (WHO) and UNICEF, thereby contributing to the global program to eradicate polio. BBio is part of the Poonawalla Group, owner of the Serum Institute of India, the world’s largest vaccine manufacturer. BBio is investing in the modernization and expansion of its production capacity.