Quality Assurance (QA) Manager (m/f/d)

We are seeking an experienced Quality Assurance (QA) Manager to lead and further develop our quality and compliance framework across Europe. In this role, you will ensure adherence to GCP guidelines and applicable regulatory requirements (FDA, EMA, ICH), while overseeing our Quality Management System (QMS) and audit activities.

You will act as the central QA contact for internal stakeholders, vendors, and external auditors, and play a key role in maintaining inspection readiness across the organization.

• Ownership and continuous development of the Quality Management System (QMS)
• Planning, conducting, and reporting of internal and external audits (e.g. vendors, investigational sites)
• Acting as QA representative during regulatory inspections and sponsor audits
• Oversight and tracking of CAPA processes through to closure
• Management of SOPs, Working Practices, and document change control
• Ensuring compliance of training and qualification documentation
• Driving continuous improvement of quality processes and systems
• Supporting company-wide quality training and awareness initiatives
• Line management and development of QA team members (as applicable)
• Responsibility for hiring, onboarding, and performance management
• Allocation of workload and ensuring timely delivery of QA activities
• Providing guidance and quality oversight across projects and stakeholders

• Bachelor’s degree in Life Sciences, Pharmacy, or related field
• 10+ years of experience in clinical research, including 4+ years in GCP QA
• Proven experience conducting audits (e.g. vendors, sites, systems)
• Solid understanding of GCP and regulatory frameworks (FDA, EMA, ICH)
• Experience working with QMS and controlled documentation
• Prior experience in team leadership or mentoring
• Structured, independent working style with strong decision-making skills
• Fluent English (written and spoken)

• 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.

• Europe-based position (remote/hybrid depending on location)
• Willingness to travel to Münster approximately once per quarter, with additional travel as required to support audits
• Occasional international travel required