Beschreibung

In this role, you will ensure the highest quality standards by maintaining inspection readiness, collaborating with various teams, and overseeing compliance with regulations. Your day-to-day responsibilities will involve preparing critical documents and leading continuous improvement initiatives.

Anforderungen

• •Degree in Pharmacy, Biology, Biochemistry, or Medicine
• •Extensive experience in QA functions and cGxP regulations
• •Familiarity with aseptic processes and Cell & Gene Therapy
• •Experience in preparing for inspections by health authorities
• •Superior critical communication skills and risk identification
• •Fluency in English and German with exceptional presentation skills

Aufgaben

• •Maintain inspection readiness from a QA perspective
• •Collaborate with operational departments and project managers
• •Implement systems for continuous monitoring of manufacturing processes
• •Ensure compliance with GxP, EU Guidelines, and 21 CFR 820.20b.3
• •Conduct assessments of new regulatory requirements
• •Prepare and review critical quality documents
• •Approve batch records, SOPs, test procedures, and risk assessments
• •Lead initiatives for continuous improvement of GMP compliance
• •Align QA topics across Cell Factories
• •Establish professional communication channels
• •Facilitate information exchange between QA and operational departments
• •Develop measures to address audit deficiencies
• •Track actions related to compliance gaps
• •Support decentralized manufacturing and point-of-care approaches
• •Serve as the primary contact for external support activities
• •Oversee employee qualification monitoring

Benefits