QP / QA Manager (clinical trials)
- 36 - 40 uur ,
- 32 uur
- MSc ,
- PhD (+)
- Quality Assurances QA ,
- Scientific Management
As the Managing QP / QA manager you are responsible for all quality related aspects for clinical drug product approval, including overseeing regulatory and laboratory quality. You are involved in from phase 1 studies scaling up and ensuring production, quality management systems (QMS) and work with CRO/CMO's meet quality guidelines.
As a QP you are the in-house expert for regulatory and quality. The company is in a scale-up phase and you are responsible to set-up and align quality procedures and protocols for manufacturing, product release, audits, QMS and also for the analytical laboratory activities.
In this Principal Qualified Person position, you supervise three (lab) technicians and 2 other (junior) QP/QA staff in the company. In this crucial pivotal role, you work closely with the CEO and management.
This is a permanent role, based in Oss - the Netherlands, for an experienced QP.
What are we looking for in the new QP / QA Manager (clinical trials)?
For this job, we are looking for:
- Finished MSc (of PhD) in pharmacy, biochemistry or related field.
- At least 5 years work experience as a Pharmacist, QP and/or analytical laboratory manager within the (bio)pharmaceutical industry.
- Registered and licensed Qualified Person in the Netherlands (must)
- Quality and regulatory experience of current EU GMP/ICH guidelines
- Good technical and preferably some laboratory experience and expertise
- Good command in English and preferably also Dutch.
What can you expect from this company?
Employment benefits QP / QA Manager (clinical trials)
- Permanent position
- Salary between € 5000 - 9000 per month, depending on experience level
- Challenging work environment
* laboratorium, qualified person, apotheker, quality assurance, GMP, GLP, GcP, ICH, responsible person