international, meaningful, curious
IMC. It's all in me.
Head Regulatory Compliance (f/m/d)
About IMC Krems
Our university offers students, lecturers and employees many opportunities for their personal development. We believe that translating knowledge into business practice is a creative process. We implement this transition in partnership with our professional community of academics, administrative staff and students.
IMC Krems is committed to promoting equal opportunities and diversity. This means that we particularly welcome applications from women, people from international backgrounds and people with disabilities or chronic conditions.
You are a pioneer in your field
- Ensure that all processes and activities at the Institute Krems Bioanalytics are in compliance with regulatory guidelines, including but not limited to FDA, EMA, and other relevant regulatory bodies.
- Oversee all quality assurance (QA) work and set priorities for the QA department, including establishing and maintaining effective quality systems.
- Manage a team of QA professionals and provide guidance and training to ensure compliance with applicable regulations and guidelines.
- Establish a consulting track in the area of GxP, including developing and delivering training programs and providing regulatory compliance consulting services to clients.
- Responsible for client acquisition in the GxP consulting field, including developing and implementing marketing strategies to attract new clients and expanding the company's presence in this field.
- Monitor and analyze regulatory developments and industry trends to ensure that the company is informed of any changes in regulations and guidelines that may affect our services.
- Collaborate with other departments within the company to ensure that all regulatory compliance requirements are integrated into our processes.
- Represent the company in regulatory inspections and audits, responding to any findings and ensuring that all corrective actions are taken in a timely and effective manner.
- Develop and maintain relationships with regulatory authorities and industry groups to ensure that the company is aware of any changes in regulations and guidelines and to promote best practices in regulatory compliance.
You have a cosmopolitan profile
- Scientific education (minimum Bachelor/Master Fachhochschule or University) in natural sciences
- At least 5 years of professional experience in Quality Assurance , expert on GxP regulations and guidelines, including FDA and EMA requirements.
- Experience in team leadership , people management and good communication skills.
- Experience in customer acquisition in the field of GxP Consulting.
- Willingness to travel
- Excellent English skills (oral and written). Proficiency in German is of advantage
- Excellent computer skills (MS-Office)
We offer you appreciative services
Cutting-edge equipment
Trailblazing research methodsIMC University of Applied Sciences Krems is not subject to a collective agreement. The gross salary for this position is EUR 56.000,-- per year on the basis of full-time employment
40 hours per week) and a Master's degree. Specific salary classifications are made taking into account qualifications and professional experience.
About IMC Krems
Our university offers students, lecturers and employees many opportunities for their personal development. We believe that translating knowledge into business practice is a creative process. We implement this transition in partnership with our professional community of academics, administrative staff and students.
IMC Krems is committed to promoting equal opportunities and diversity. This means that we particularly welcome applications from women, people from international backgrounds and people with disabilities or chronic conditions.
What makes us special
We offer an innovative and internationally oriented working environment of a first-class teaching- and research facility in the middle of the Wachau Natural and World Heritage Region.
IMC Fachhochschule Krems GmbH
Piaristengasse 1
3500 Krems
Further Information
If you are interested, please submit online your full application documents (cover letter, CV, certificates).
