Head of Quality Assurance Institute Krems Bioanalytics (m/f/d)
About the Institute Krems Bioanalytics
Krems Bioanalytics, is a contract research organization of IMC University of Applied Sciences Krems, offering state-of-the-art bioanalytical services in the fields of immunology, hematology and oncology since 2014. We have many years of expertise in the development and validation of customized and GxP-compliant analytical assays for large molecules and vaccines. We offer sample analysis for early and late preclinical studies (R&D or GLP) and for clinical trials (GCP)..
international
meaningful
curious
IMC. It´s all in me.
Your tasks
You are a pioneer in your field
- Plan, implement, integrate, monitor and continuously improve the risk-based QMS and related procedures in accordance with the overall IMC management system and relevant compliance requirements including but not limited to GLP, IVDR, ISO9001, ISO15189 and GMP.
- Oversee overall Quality Assurance (QA) including the establishment and maintenance of effective quality systems.
- Lead a team of QA professionals and prioritize the QA department.
- Provide guidance and training to ensure compliance with applicable regulations and policies.
- Monitor and analyze regulatory developments and industry trends to ensure the company is aware of any regulatory and policy changes that may impact services.
- Representing the company during regulatory inspections and audits, responding to findings and ensuring that all remedial actions are taken in a timely and effective manner.
- Responsible for implementing processes to ensure that the selection, validation, testing, use and maintenance of software, hardware and other computerized system components in GxP environments comply with regulatory requirements.
- Assist in the acquisition of new projects and business development with customers.
Your profile
You have an open-minded profile
- Scientific education (Bachelor/Master, college or university) in natural sciences - at least 5 years of professional experience in Quality Assurance, expert on of GxP regulations and guidelines, including FDA and EMA requirements.
- Experience in CS validation is an advantage
- Experience in team leadership, people management and good communication skills.
- Excellent English and good German language skills (written and spoken)
- Very good computer skills (MS-Office)
You are a communicative and empathetic personality with a proactive and creative way of thinking. A professional demeanor and respectful interaction with others are important to us. We expect a high level of organizational skills, initiative and a sense of responsibility.
Your benefits
We offer you appreciative services
We offer you appreciative services
Flexible working models
Working from home
Trailblazing research methods
IMC Krems is not member to any collective agreement. The minimum annual gross salary for this position is EUR 56.000,-- on the basis of full-time employment (40 hours per week) and a Master degree. Depending on professional qualifcations and experience, we are willing to overpay.
About the Institute Krems Bioanalytics
Krems Bioanalytics, is a contract research organization of IMC University of Applied Sciences Krems, offering state-of-the-art bioanalytical services in the fields of immunology, hematology and oncology since 2014. We have many years of expertise in the development and validation of customized and GxP-compliant analytical assays for large molecules and vaccines. We offer sample analysis for early and late preclinical studies (R&D or GLP) and for clinical trials (GCP)..
What sets us apart
from the rest
Highly ranked in terms of both teaching and research, we can offer an innovative, international working environment in the heart of the Wachau Cultural Landscape and World Cultural Heritage Region.
IMC Hochschule für Angewandte Wissenschaften Krems GmbH
Piaristengasse 1
3500 Krems
Austria
Further Information
(cover letter, CV, relevant certificates).