Quality Assurance Manager/Qualified Person

“Will you support us making cancer a chronic disease?”


We are an international biotech company with about 40 employees and 14 nationalities based in Oss, driven by knowledge, skills, and teamwork. Together we research, develop, and manufacture new therapies to create unique value with the ambition to cure cancer.

Glycostem is looking for an, energetic, proactive, precise and flexible team worker to support us as QA Manager.

Fulltime position
As QA Manager you will be responsible for managing a team of young and driven QA-professionals in a GMP environment on activities related to cell therapy. You will lead your team in maintaining a quality system for allogeneic cellular products in accordance with GMP and applicable international guidelines.

The role entails a broad range of duties and the specific areas of focus will be dependent on the skills and experience of the person holding the role.

If you have experience working as a QP it will be highly interesting in this position, you will serve as the Glycostem GMP expert and in this role you can make an important contribution to advancing this exciting new area of drug development.

You must identify and resolving quality issues with appropriate supporting documentation and must provide relevant GMP support in and outside the QA department. You must be able to weigh the risk of the event and look for an efficient yet compliant solution. You are a people-oriented team leader, pro-active thinker, accurate, precise and constructively critical, experienced mentor and able to train staff on basic quality tasks.

In this role you must implement procedures for attaining specific goals, objectives and receive guidance in terms of broad goals. Only the results of work are typically reviewed.

Principal accountabilities of the QA Manager
• Manages all aspects of QA systems for a phase I to commercial GMP cell therapy manufacturing facility.
• Responsible for managing the QA department in a fast-growing environment
(work planning, staffing and training, review and approval of batch/unit
records).
• Consult with CEO on decisions to ensure alignment and agreement.
• Review and approve Glycostem SOPs, forms, protocols and reports.
• Review and approve Glycostem equipment qualifications.
• Ensuring changes are justified; procedures are followed and contain
appropriate associated reference.
• Review and approve deviations, CAPAs and change controls within area of
focus and partner with other departments on these topics as the Quality expert.
• Ensuring vendor management program is in place and support all Glycostem
operations.
• The QA Manager is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP).
• As a QP perform final release of the pharmaceutical product for clinical use or manage contract QP(s).
• Involved in clinical shipments

Qualifications
The job as QA Manager will be held by a person with:
• MSC in science, biotechnology or related discipline with focus on cell biology and/or human cell culture technologies (stem cells, primary cells and/or tissue culture)
• 5 – 10 years’ experience with GMP certified industrial QC laboratory and or manafucturing
• 5 – 10 years’ of industrial experience with quality systems
• Good proficiency in English (work language)
• ATMP and or Biopharmaceutical experience would be preferred
• Preferably working as a registered QP
• Good knowledge of standard MS-Office product.
 
Are you the one we are looking for?
• We offer a dynamic job with a lot of challenges, in which you can further develop your talents. You will work with small and passionate colleagues in an innovative organization. Besides this, you can count on:
• After a successful trial period a permanent contract is extended
• Competitive salary, after you first year your salary will be adjusted accordingly with your performance and dedication
• Pension premium contribution
• Travel allowance or public transport reimbursement
• 25 holidays
• Stock option plan
 

Do you have what it takes?
Please convince us by sending your motivation and CV in English to Liana van Genuchten (HR@Glycostem.com). Selected candidates will be invited for a face-to-face interview with the line management.

Want to know more?
E-mail our HR department at HR@Glycostem.com for more information about Glycostem and selection process.

Recruiters should not contact us.
Please be aware that your application means that the information you provide will be shared by and with HR and the employees who are involved with the procedure. In case the procedure with you ends, your application and provided information will be deleted within four weeks after the moment you have been informed. Your name and date of application will be registered in our database for statistical use and status only. By applying you agree with and have taken notice of these conditions.

 

Pivot Park Captains' Dinner

10 years ago, Pivot Park opened its doors to the world. Thanks to your commitment, support and confidence, we have been able to grow it into the successful and innovative biopharmaceutical campus it is today.

Now it’s time to celebrate!

We are therefore delighted to invite you – along with all your fellow CEOs at Pivot Park – to a special night out featuring inspiring art, a wonderful dinner and lots of opportunities to network and exchange ideas.

Erwin Wurm | Am I a House?

For the first time, the artist shows a cross-section of his work, from Narrow Furniture to One Minute Sculptures, within the walls of a historic building. Villa Constance, a former home that today houses Museum Jan Cunen, is not only a location but also part of the conversation. Because what exactly is a house?

#100YEARSPHARMAFUTURE

The development of medicines in Oss began one hundred years ago. It was then that the foundations were laid for what would become a flourishing pharmaceutical sector in the Netherlands, leading to groundbreaking discoveries such as insulin and the anti-conception pill.

Today, the entire chain is still represented in Oss, from early-stage research to the commercial scale production of medicines. Working in Oss, we focus on the health of people all over the world. Employees at dozens of companies large and small put their heart and soul into new medicines, products and services that will improve lives worldwide. Together, our strength lies in our combination of broad knowledge about the development of medicines and a thorough understanding of the requirements of high-quality production.

This shared past and common values stimulate strong bonds among everyone who works in pharmaceuticals in Oss. We build on qualities, expertise and networks that go back decades. And with a wide variety of pharmaceutical companies, suppliers and scientific institutions all located nearby, we offer an attractive business climate and an excellent basis for international collaboration.

We are proud to work together to create a better and healthier future for all, a collaboration that in turn fuels growing employment: today, most pharmaceutical jobs in the Netherlands are in Oss. Here we connect talent and companies and stimulate entrepreneurship, while our expert employees are our most important asset. Their drive ensures that Oss has an influence on health all over the world.

Pharma in Oss offers endless opportunities to startups and talent in a city and region that is a joy to live and work in. We are committed to collaboration and sustainable and successful entrepreneurship. Oss’s pharmaceutical companies are intrinsically competitive while also being committed to quality and safety. This, plus their focus on new health solutions and contemporary technology, makes us a leader in our pursuit of a better life for people worldwide.