Quality
Senior Quality Assurance Officer

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

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

The goals of the QA department: responsible for quality assurance at any GXP stage of testing, manufacturing, distribution or other operational processes, relating to approval of specifications, test methods, procedures, suppliers, contract companies, manufacturing instructions and validation documentation, review and approval of manufacturing documentation, testing and validation activities, release of products and ensuring quality systems procedures for products or services.

Glycostem is looking for an ambitious, energetic, proactive, reliable and flexible professional with humor to support us as senior QA officer.

Full time position

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.

The Sr QA Officer will be part of a young team which consists of driven QA- professionals in a GMP environment on activities related to cell therapy and regenerative medicines.
In this role he/she will be responsible to ensure the quality cell therapy products to support product disposition, together with the Qualified Person, intended for clinical studies. Next to this the Sr QA Officer will support the management and improvement of Glycostem quality systems.

The Sr Quality Officer will work closely together with Development, Operations and Quality Control departments.

Main responsibilities of the Sr QA Officer

•    Review of batch manufacturing records and associated deviations, change controls.
•    Review of media simulations and environmental monitoring data
•    Compile product release packages to support product disposition by the QP
•    Contribute to manage and improve the Quality System, implement and improve current procedures and processes such as the management of change notifications, internal and external audits and vendors.
•    Write, implement, review and maintain procedures and other QA related documentation in alignment with applicable GxP guidelines.
•    Interacts directly with other departments with respect to training, change control, CAPA, deviation, risk assessments audit management and documentation.
•    Maintain and evaluate quality indicators together with stakeholders such as manufacturing and warehouse.
•    Be able to weigh the risk of the event and provide the most efficient compliant solution.
•    Performing and reviewing internal and external audits, as lead auditor, to determine compliance with applicable guidelines (like GMP, GLP, GDP).
•    Represents QA department in significant complex projects (CMC projects) with respect to e.g. manufacturing improvements/efficiency projects.
•    Perform other duties as assigned.

Education, skills and experience

The job as Senior Quality Assurance Officer will be held by a person with:
•    BSc /MSc. in Science, Biotechnology or related discipline with focus on cell biology or human cell culturing techniques (stem cells, primary cells and/or tissue culture)
•    5 years’ work experience within a GMP environment in a biopharmaceutical or cell therapy company with at least 3 years’ experience in Quality Assurance
•    Good understanding of GMP’s, regulations, and compliance in a GMP manufacturing setting
•    Good proficiency in English
•    Good knowledge of standard MS-Office products
•    Attention to detail, works effectively individually and with teams.

Duration of employment:

After a successful probation period a permanent contract is extended.

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 the 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.