Head QA Systems and Compliance

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

For the expansion of our team, we are looking for a full-time head QA Systems and Compliance. In this role you will be responsible for implementing and maintaining compliant and effective pharmaceutical quality systems. You will decide on the strategic vision related to quality documentation, qualification of equipment, systems and utilities including computerized systems and data integrity. You will manage the QA Systems and Compliance department (approximately ten employees). You will support management review of Synthon Biopharmaceuticals, spotting and analyzing trends and promoting continuous improvement of the quality systems. Furthermore, you will support the Synthon Biopharmaceuticals organization with GMP related training.

Your responsibilities include:

  • Defining QA approach on the implementation of new/updated guidelines
  • Ensuring appropriate documentation control (including data integrity) and appropriate implementation and maintenance of PQS and related quality systems
  • Writing and maintaining the quality manual, site master file and procedures
  • Performing internal and external audits and provide support during external audits from authorities or customers
  • Ensuring appropriate vendor management.

Your profile

Your cover letter and CV will demonstrate that you have:

  • A bachelor’s degree
  • A minimum of 5 years of work experience in the pharmaceutical or biopharmaceutical industry in e.g. QA, QC, production, IT or development
  • Extensive knowledge of quality assurance, compliance and validation in the pharmaceutical industry
  • Knowledge of the regulatory requirements and expectations of the recognizing regulatory authorities 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.

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

Important dates

Please send your application before 31 October 2019. The first round of interviews will take place on 8 November 2019; the second round will take place on 14 November 2019.

Information and application

Contract hours: preferably 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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