Quality Assurance Manager* (Reporting to Director/Head of Quality Assurance) in Deutschland bei AiCuris GmbH & Co KG

• Manage the creation, review, and revision of SOPs to ensure compliance with regulatory requirements.
• Collaborate with cross-functional teams to resolve quality-related issues and implement corrective and preventive actions.
• Develop and implement training programs for employees at all levels.
• Support audit planning (e.g., coordinate with external auditors) and audit management.
• Support outsourced activities from a quality perspective.
• Support inspection management (internal and external).
• Conduct internal audits to assess compliance with quality standards and identify areas for improvement.
• Identify and support continuous improvement initiatives.

• Bachelor's degree, master or higher in a relevant scientific discipline (e.g., biology, chemistry, pharmacy).
• Several years of experience in a GxP regulated environment, such as quality control or quality assurance or other relevant areas within the biotechnology or pharmaceutical industry.
• Strong knowledge of EU and FDA regulations
• Experience managing quality systems, including document control, deviations and CAPA management.
• Experience developing and delivering training programs.
• Ideally, experience in late-stage clinical development
• Experience in implementation of clinical and/or non-clinical development processes
• Experience in computerized system validation in a GxP regulated environment
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Detail-oriented with strong analytical and problem-solving abilities.
• Fluency in English.

• Unique corporate culture: Scientific excellence, a collaborative working environment and the passion to improve the lives of patients defines our work. With us, you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity, inspiration, as well as trustful collaboration.
• Development: We encourage people to grow and strongly support individual development and learning opportunities.
• Flexibility: Embracing flexible working accommodations, we enable our people to integrate business into their personal life.
• Benefits: Employer-funded pension comes along with an attractive benefits package

AiCuris Anti-infective Cures AG is a leading clinical-stage pharmaceutical company developing novel, therapeutic candidates for the prevention and treatment of severe and potentially life-threatening infectious diseases in immunocompromised patients. Our front-runner drug Prevymis®, a prophylactic treatment for CMV infection in transplant patients, is marketed globally since 2017 by MSD (Merck & Co.). Prevymis® is followed by an innovative pipeline of antiviral agents including our wholly owned therapeutic candidate Pritelivir, which is currently in phase III pivotal clinical development.