Quality Manager Human Pharmacological Center (m/w/d) Full-time or part-time 75%

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Then you're right with us. As a staff expert, we support various companies in finding appropriate specialist and executives (m/w/d) and are at your side as a career advisor.

We are currently occupying the following position for our well-known customers in the area of Chemistry/Pharma, based in Biberach at the tear:

Quality Manager (m/w/d)

This position is a hybrid working model that can be covered from the Home Office on 1 to 2 days per week. The incorporation takes place on site.

Take advantage of your chance and become part of this success story!

In your new position, organize/support in the preparation, execution and follow-up of inspections, internal and external audits and assessments including timely creation of action plans and their follow-up They are responsible for the creation and management of Controlled Documents and Templates for HPZ processes (Human Pharmacological Center) as well as for the verification of relevance for HPZ functions and matching with SOP distributor lists and incorporation lists In addition, you take over the independent implementation of quality controls, e.g. Check relevant audit procedures and documentation (source data, CRFs, ICs, internal process descriptions, etc.) and initiation of process improvement measures and CAPAs They also serve as support for the HPZ team through advice and assistance on issues related to quality, processes, SOPs, improvement activities and data protection

They have a completed degree with multiannual relevant experience or an equivalent qualification with relevant training/further training and many years of professional experience In principle, various disciplines are conceivable, for example a science study (e.g. biology, pharmacy, chemistry), pharmaceutical sciences/clinic research, health sciences/Public Health, quality management/Regulatory Affairs. Or a Master's degree course Clinical Trial Management, GCP or Quality Management in Healthcare In addition, you can present a long-term experience in clinical trials of Phase 1 (e.g. as Study Nurse, Clinical Research Associate, GCP Auditor) A very good understanding of clinical research, quality management and regulatory requirements is provided Very good knowledge of relevant international and national regulations, e.g. GCP, AMG, MPG, GCP-V, relevant guidelines (ICH, FDA, EMA) are essential for this site In addition, you already have experiences in the quality management and training of employees They convince by their ability to identify problems independently and at an early stage as well as to solve them in a highly independent and targeted manner. In addition, you are convinced by your team capacity as well as effective, efficient and in particular need-oriented communication and cooperation with cultural empathy. Flowing German and English skills complete your profile successfully

We pay a collective salary which depends on the tariff of IG Chemie Baden-Württemberg, as well as possibly Industry supplements, holiday and Christmas money as well as shift supplements according to the GVP tariff agreement Your employment contract is unlimited In cooperation with Allianz and the Nuremberg Insurance, we offer an occupational pension scheme You will receive a high-quality professional equipment for protective and workwear as well as medical precautions by the Werksarztzentrum If necessary, we finance individual training courses that you will continue to do in the long term With us, employees receive premiums on special occasions - for example 25 euros for birthday or 120 euros as a thank you for a daring colleague As an expert employee you get exclusive discounts in over 600 shops and online shops We are also happy to advise you on other places and career opportunities JOBV1_EN