Senior Quality Assurance Officer

About Synthon Biopharmaceuticals

Synthon Biopharmaceuticals focuses on development of innovative medicines, including antibody-drug conjugates, in two key therapeutic areas: oncology and autoimmune diseases. In the coming years, we aim to deliver on our promise to introduce new medicines for diseases with high unmet medical need.

We are inquisitive, entrepreneurial and independent. We make creative choices, and are building a promising portfolio of next-generation medicines.

Synthon Biopharmaceuticals is based in Nijmegen, the Netherlands, where close to 300 staff work at our state-of-the art biotech campus.

We are interested in result-oriented people with a sharp mind and entrepreneurial spirit, who can contribute to our ambition to provide solutions to the healthcare challenges of today and tomorrow.

Job profile

We are looking for a full-time Senior Quality Assurance Officer, to support Synthon Biopharmaceuticals’ Qualified Person (QP) in handling relevant quality issues and act as deputy when required. You will be responsible for releasing drug intermediates and preparing batch release in close cooperation with the QP. You will also review and approve QA documentation such as validation protocols and reports, risk assessments, procedures and work instructions and provide excellent advisory service to R&D and manufacturing departments for QA related systems. Advising on the implementation of new and revised guidelines and participating on behalf of QA in the set-up of new quality related systems are included in your tasks as well. Finally, you will be writing, maintaining and approving procedures when needed, performing internal and external audits and offering support during critical external audits from customers and/or authorities.

Your profile

Your qualifications are:

  • Level of experience and education: bachelor / master
  • Practical knowledge of monoclonal antibody (mammalian cells) processes, USP knowledge is a plus
  • GMP work experience in the biopharmaceutical industry, e.g. QA, QC, production
  • Knowledge of the regulatory requirements to enable assessment of the applicability and compliance with such laws, regulations, and standards
  • Excellent verbal and written communication skills and an outstanding command of the English language
  • Biotechnological knowledge and experience with development of new medicines.

In interviews you will be able to demonstrate that:
You are motivated, pragmatic and result oriented. You have the required skills to work in teams and you are able to build and maintain relationships with customers and colleagues.

Important dates

Please send your application before 31 October 2019. The first round of interviews will take place on 12 November 2019 and the second round of interviews will take place on 22 November 2019.

Information and application

Contract hours: full time (40 hrs).
Location: Nijmegen.

For further information, please contact Kaat De Moor, head Quality Assurance at tel. +31 (0)24 372 77 00. If you are interested in this challenging position, we look forward to your application. You can apply via the apply button / link.

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