Profil is an internationally renowned CRO in the field of metabolic diseases, founded in 1999.

For many years, we have been working closely with the pharmaceutical industry to develop new drugs for the treatment of diabetes and related diseases. We also intensively support the further development of known active substances. Furthermore, we conduct vital research regarding various other exciting applications such as novel routes of insulin administration or the measurement of blood glucose concentrations.


Our many years of experience have enabled us to build up comprehensive scientific know-how and a unique expertise in the field of metabolic diseases. Profil currently employs around 400 people who make an important contribution to improving the quality of life of people with diabetes.


We are looking for a





Senior Quality Assurance (QA) Manager (f/m/d) Clinical Trials




We are seeking an experienced and motivated Senior Quality Assurance (QA) Manager - Clinical Trials to further develop our QA function within the clinical research environment. This role combines hands-on quality expertise with close collaboration with cross-functional and international stakeholders.

Plan, conduct, report and track internal and external audits (e.g. process audits, vendor qualification audits, system and study specific audits and inspections)
Ensure compliance with GCP, ICH guidelines, FDA regulations, applicable regulatory requirements, and company standards
Own and manage Deviation and CAPA processes, including root cause analysis, tracking, and effectiveness checks
Drive risk management activities, including risk assessments and mitigation strategies
Lead and support change management processes related to quality systems and clinical operations
Responsible for the creation, review, approval, and lifecycle management of QA SOPs
Preparation of role-based training materials and conduct of training courses in the GCP/FDA regulated setting
Prepare quality metrics, management reports, and audit summaries for upper management
Act as a key QA contact for regulatory inspections and sponsor audits
Collaborate closely with Clinical Operations, Project Management, Regulatory Affairs, Data Management, Medical Writing and external partners
Support continuous improvement initiatives within the Quality Management System (QMS)
Review and approve validation documentation (e.g. validation plans, risk assessments, test scripts, validation reports) for computerized systems, including eQMS and other GxP-relevant systems

University degree in Life Sciences, Pharmacy, Medicine, or a related field

Several years of professional experience in Quality Assurance within clinical trials
Senior QA professional
Strong knowledge of GCP, ICH and international regulatory requirements (e.g. FDA regulations)

Demonstrated experience in:

Audit planning, performance, and reporting
Deviation and CAPA management
Risk management
Change management
SOP and training management



Fluent in German and English, both written and spoken

Willingness to travel nationally and internationally, particularly within/to Germany, within Europe and the USA

Strong organizational, analytical, and problem-solving skills
Confident communication style and ability to work with stakeholders at all levels

A responsible senior role in an international clinical research environment
High level of autonomy and the opportunity to actively shape QA processes
Collaboration with global teams and exposure to international projects
A thorough and practice-oriented onboarding
Performance-based compensation and flexible working hours
A company culture strongly characterized by trust and collegiality
An exciting workplace with opportunities for professional and personal development, for example development into a team lead function