Senior Manager IT QA (life sciences)

The organisation

You will work for an international biotech company specializing in the creation and development of innovative differentiated antibody therapeutics for the treatment of cancer and the improvement of the lives of cancer patients.
The company has been active for almost 25 years and they now have over 1000 people working for them. Their headquarters are in Denmark and next to this office, they have sites in the US, Japan and the one in Utrecht that you might join!

The position

As Senior Manager IT QA, you will contribute to establishing and maintaining the oversight of computerized systems and you will be supporting several IT validation projects. You will be part of a global QA team and report to the Team Lead IT QA.

Tasks & responsibilities

Your responsibilities include:

• Ensuring compliance with applicable regulatory requirements of the computerized systems that are or will be implemented;
• Quality oversight, review, and approval of validation processes and validation activities performed across the regulated parts of the organization;
• Identifying and implementing improvements to the IT system life cycle and validation processes to ensure a pragmatic and risk-based validation approach;
• Supporting IT in establishing and maintaining an IT infrastructure qualified for intended use i.e. in supporting validated systems;
• Securing compliance with internal procedures and external GxP demands;
• Preparing computerized system risk and regulatory impact assessments and other evaluations, e.g. periodic reviews;
• Coordinating validation activities in compliance with corporate policy, local procedures, and regulatory expectations;
• Reviewing and assisting in developing departmental standard operating procedures (SOPs) and validation programs;
• Supporting vendor qualification activities;
• Supporting infrastructure qualification/computerized system validation projects as allocated.

Candidate profile

To be successful as a Senior Manager IT QA, you need between 5-10 years of IT QA Management experience within the Life Science industry. Ideally, you have a degree in a Life Sciences field combined with IT education/courses. You combine this with documented experience with implementing and validating IT systems, as well as supporting and maintaining existing IT systems keeping them in a validated state. You also have experience with cloud-based software, internally hosted systems, and qualification of IT infrastructure, e.g. as part of an ITIL program.
You are fluent in English, Dutch is not required for this position.

The offer

Your new employer offers you a suitable salary that fits your experience and expertise. Of course, you will also get good secondary benefits such as a 1 year contract with the intention to convert to a permanent contract afterwards. They also offer an annual bonus, holiday pay (8%), stocks, a good pension scheme (2/3 paid by employer), 25 holidays, travel expenses and a hybrid working policy.
You will be working in an informal, multicultural environment where inclusiveness, openness and support are key words.

Interested?

You can apply for this postion by using the link below.