Quality Assurance Specialist (m/f/d)

Your mission

As a Quality Assurance Specialist, you ensure compliance with GCP guidelines and applicable regulatory requirements (FDA, EMA, ICH) as well as internal quality standards. You play a key role in maintaining our Quality Management System (QMS) and ensuring inspection readiness through robust documentation and training processes.

Your Responsibilities

• Management of controlled documentation (SOPs, Working Practices, training documents) including creation, review, and change control
• Maintenance and continuous improvement of the Quality Management System (QMS)
• Coordination of document reviews, approvals, and training assignments prior to effective dates
• Support of internal and external audits, including preparation and follow-up of findings
• Management and tracking of CAPA measures
• Maintenance of training records, qualification files, and compliance documentation

Your profile

• Degree in Life Sciences, Pharmacy, or related field (or equivalent experience)
• Minimum 4 years in clinical research, including at least 2 years in GCP Quality Assurance
• Strong knowledge of GCP and regulatory frameworks (FDA, EMA, ICH)
• Experience with QMS and controlled documentation systems
• High level of accuracy, structure, and responsibility
• Very good English skills (written and spoken)
• Willingness to travel to Gernab headquarters on a quarterly basis and to provide on-site support during audits as required.

What do we offer? Great Opportunities!

• Hands-on mentality from the beginning
  We support you at all times in your development and collaboratively find projects that you enjoy and offer significant creative freedom.
• Flat hierarchies, an open feedback culture, and a fantastic team spirit
  We emphasize a culture of informal address (Duz-Kultur) and an open-door policy! Following our motto "Stronger Together," you can expect a motivated team. We tackle challenges together!
• Welcome to our innovative work environment
  Our hybrid workplace combines the best of both worlds - the flexibility of working from home and the dynamism of collaborative work in the office.
• Start-up meets Grown-up mentality
  Experience the spirit of over 25 years of clinical trial expertise combined with the latest innovative trends in the industry.
• Exciting insights into clinical research
  Our team consists of many long-term employees who are eager to share their expertise with you.
• Learning & Development Culture Personal and professional growth is a priority for us!
  We believe that continuous learning and professional development are crucial for the individual success of our employees.
  Are you interested? Then we look forward to receiving your meaningful application, including your salary expectations and details about the earliest possible start date! As you will be working in an English-speaking team, please submit your application documents in English .

About us

Symbio is a globally operating, specialized Clinical Research Organization (CRO) with locations in the USA and Europe. The mission is to improve the quality of life for thousands of people through innovative clinical research, prioritizing fast, transparent processes that allow patients to benefit from new treatments sooner.
Symbio values a flexible work culture that empowers dedicated team members to manage their work independently, whether from home or in an inspiring office environment. For those looking to advance their career while making a meaningful impact on people’s lives, Symbio offers an ideal opportunity.