Quality Assurance Manager* (Reporting to Director/Head of Quality Assurance)

at  AiCuris GmbH Co KG

YOUR MISSION

At AiCuris, ensuring quality of our products and processes is of the highest importance. As a Quality Assurance Manager* you will support the Director/Head of Quality Assurance and work together with our project-teams during drug development up to approval regarding all manufacturing, non-clinical and clinical quality assurance aspects related to our development projects covering small molecules and biologics.

Responsibilities

• 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.

ABOUT US

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.

Passionate about our mission to develop anti-infective therapeutics for patients in need, a team of internationally recognized experts is driving our research and development to improve the lives of patients. We believe in a culture of trust and transparency, where feedback is considered an opportunity to contribute to each other’s personal and professional growth. We hire people who are collaborative, adaptable, communicate well, and love to learn.

• AiCuris is an employer that supports equal opportunities, diversity and inclusion. We welcome applications from people regardless of their national origin, skin color, religion, gender, age, marital status, disability, sexual orientation, gender identity or other legally protected characteristics.

• 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