(Senior) Manager Quality Management (m/f/d) Preclinical & Clinical Trials

Our mission at Fresenius Kabi Global QA is dedicated to delivering ethical and trustful consultancy and auditing services for preclinical and clinical studies to foster quality in all aspects in a GxP environment.

Our main aim is to ensure the quality compliance of preclinical and clinical studies against the applicable regulations and guidance documents not only by conducting audits and qualifying vendors but also by having the quality oversight, by trending audit and inspection findings and by providing consultancy for all internal stakeholders.

Our vision is to support the functions during the entire study lifecycle by providing professional guidance based on the current understanding and thinking of the regulatory authorities, upcoming changes and support in practical and compliant implementation of those.

Your assignments

• Plan and execute independent GCP audits (e.g., document audits, CRO/vendor audits, site audits, process audit, system audits, audits of critical data points) for clinical trials worldwide, including biosimilars.

• Provide expert consultancy on GCP requirements for in-licensing projects.

• Prepare, support, and assess risks for regulatory inspections and clinical studies.

• Develop and update SOPs while ensuring compliance with current regulations.

• Train internal QA colleagues and stakeholders on relevant regulations.

• Lead gap assessments and implement corrective actions to maintain quality standards.

Your profile

• University degree in natural sciences and minimum of 8 years of professional experience in quality assurance for clinical trials

• Highly qualified GCP auditor with extensive experience (5+ years) and expertise in relevant regulatory requirements, laws and guidelines, SOPs and quality management

• Expert knowledge of GCP regulations, computer system validation, and risk management in clinical trials

• Strong prioritization skills, decision-making abilities, and the capacity to excel under pressure

• Highly motivated, self-initiated, and willing to travel

• Proficient in English, both written and spoken, with excellent MS Office skills

If you are a dedicated and experienced professional in quality assurance looking to make a significant impact in clinical trials and are ready to take on a challenging and rewarding role, we invite you to apply for this opportunity. Join our team and lead the way in maintaining excellence in clinical trial quality standards. Take the next step in your career and apply now!