With a practical, hands-on approach
Could you be our new Quality Manager?
Well, if you:
- Are considering a change of scenery
- Want a job with a high degree of flexibility
- Value the freedom it gives to have the opportunity of working from home and perhaps even on part time basis – if preferred
- And can see yourself thriving in a small “Professional Family” of 14 other – really friendly, forthcoming, highly skilled and helpful – colleagues
… the answer could actually be a “yes” – and you should definitely consider reading on – and getting in touch with us.
Who we are – professionally
We are a Contract Research Organization (CRO) who have specialized in Data Management and Statistics – for more than 10 years, and due to an increasing demand for our services, we have decided to expand our team with a dedicated Quality Manager
We offer all Biometrics services required in relation to clinical and device trials.
We are data managers, statistical/SAS programmers and statisticians, and our office is located in Birkerød.
Who we are – personally
When Bjarne Bodin and Peter Lipczak founded BioStata in 2010 it was with the clear vision of establishing a company build on a deliberately small team (no more than 15 – 20 people).
This was chosen in order to combine the strength of deep expertise normally found in large organizations – with the flexibility and freedom only found in small companies.
Having lived this vision for more than a decade now, we can safely say that some of the keywords describing our working atmosphere are: Trust, helpfulness, open-mindedness, kindness, responsibility, opportunity for influence – and a high degree of professional dedication to what we do.
What you can enrich the team with
To be a relevant candidate for the position, you need to have practical experience with:
- GCP requirements in relation to Biometrics services or similar
- Maintaining the QMS
- Arranging and participating in audits
- Writing and speaking English fluently
- Cooperating – and communicating – with your colleagues in a diplomatic way, that they find pleasant, inviting and motivating
In addition to this, it is real bonus (but not required) if you have experience with:
- Working with a paper-based QMS, as our currently has this format – slowly migrating to an electronic one.
- FDA 21 CFR Part 11 requirements in relation to Biometrics services
- Developing and maintaining MS Office Document templates
Your primary areas of responsibility will be defining and adjusting our processes – and make sure that we stay compliant both in terms of quality and GDPR.
In addition to this, you will also be responsible for a number of other, quality-related, activities such as keeping our CVs and Training Log regularly updated and lead the migration of our current paper-based QMS – to a digital version.
You will therefore be working together with the entire team – making us all benefit from combining decades of knowledge and experience.
If you find it appealing, you will also have the opportunity to be our face towards the customer on the quality/audit aspects of some projects – ensuring that both external and internal expectations are met.
Work is typically carried out from our office in Birkerød – or your home – depending on the nature of the task and your preferences.
So… are you tempted to join us?
Well – at this point you probably have a much better idea of this, than you did just a few minutes ago…
If you tend towards “yes” – or if you are curious about getting to know more about us and the position – please contact our CEO:
Bjarne Bodin, firstname.lastname@example.org, tel. +45 2023 5778.
We are looking very much forward to hearing from you – and perhaps welcoming you as part of the team…