Quality Manager and Qualified Person

Vacancy for a Quality Manager and Qualified Person

Full time position

At Glycostem we are recruiting a Quality Manager and Qualified Person.

The basic responsibility is to ensure that Glycostem develops and maintains a clear compliant quality strategy which will ensure cost-effective and smooth quality and product release processes.

The Quality Manager/QP:

  • is a member of the management team; and
  • will help increase the awareness of quality standards throughout the organisation.

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.

 

Responsibilities

  • Maintain the GMP quality system within Glycostem;
  • Independently manage review and approval of executed manufacturing records, analytical data, and associated documentation, including deviations and investigation reports;
  • Perform final release of the pharmaceutical product for clinical use;
  • The QP 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 authorisation (MA) and with Good Manufacturing Practice (GMP);
  • Set-up and manage a network of independent QPs working remotely to approve batch records;
  • Organise and perform Quality related Training;
  • Review and approval of Change Control requests, Deviations, Complaints and CAPA’s to ensure compliance with all applicable requirements;
  • Prepare, execute and report on internal and external audits and vendor management programs;
  • Prepare and present quality metrics;
  • Independently initiate and approve SOP updates and creation of new SOPs. Additionally, oversee review of SOPs and associated documentation to ensure review requirements are met;
  • Lead regulatory inspections;
  • Establishment of quality-specific documents e.g. Quality Risk Management Plan, Quality Agreements, Site Master File and Validation Master Plan in cooperation with applicable departments; and
  • Ensure quality processes across the supply chain comply with all applicable regulations and guidelines.

 

Education, skills and experience

The job as Quality Manager/QP will be held by a person with:

  • 5-10 years of industrial experience with quality systems;
  • Qualified QP; ATMP experience would be preferred;
  • Ability to implement complex quality framework in a simple strategy while adhering to relevant GMP standards;
  • Manage and innovate department and systems;
  • Overlook and run a cost-effective quality system;
  • Work effectively with other management team members;
  • Applies strong analytical and business communication skills, implements technical solutions to complex problems;
  • Uses broad expertise and skills to contribute to company objectives and to achieve goals in creative and effective ways;
  • Must have excellent verbal, written, interpersonal, organizational, and communication skills; and
  • Some travelling must be expected.


 We offer;

  • After a successful trial period a permanent contract is extended.
  • Competitive salary, after your first year your salary will be adjusted accordingly with your performance and dedication; 
  • Pension premium contribution; 
  • Travel allowance or public transport reimbursement; 
  • 25 holidays.


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.

Subscribe to our newsletter

If you subscribe you agree to the Privacy Notice of Glycostem Therapeutics B.V. as found on the website.