Quality & Compliance Manager (m/f/d)

Looking for a new challenge?

Do you want to actively contribute to the advancement of a future-oriented healthcare system?

Then join our Quality Assurance Team as

Quality & Compliance Manager (m/f/d)

Full-time

• Permanent
• Hybrid (Dresden or remote within Germany)

About Us

ABX-CRO is an international contract research organization (CRO) headquartered in Dresden, Germany. Since 2002, we have been supporting clients from the pharmaceutical, biotechnology, medical device, and diagnostics industries — from preclinical proof-of-concept studies to the planning, conduct, and evaluation of clinical trials. Our main focus lies in innovative therapies in oncology, radiopharmaceuticals, and molecular imaging.

To strengthen our Quality Assurance Team, we are currently looking for a motivated and detail-oriented professional to join us as Quality & Compliance Manager

Your Tasks & Responsibilities

• Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) and Information Security Management System (ISMS)
• Ensure GxP compliance, data integrity (ALCOA++), and data privacy (GDPR) across systems and processes
• Assist in the planning and execution of GCP, GMP and GVP audits
• Collaborating and monitoring internal teams and external providers to ensure compliance and quality standards are met
• Participate in risk assessments, CAPA management, and root cause analyses
• Contribute to Computer System Validation (CSV) and Computer Software Assurance (CSA) activities including preparation and review of its documentation
• Providing input on the strategy, development and implementation of artificial intelligence (AI) in our company
• Support ISO 9001 surveillance activities and preparing for ISO 27001 and SOC 2 certifications

Your Profile

• University degree in Life Sciences, Engineering, Computer Science, or a related discipline
• At least 2 years of professional experience in quality management, guideline and regulation compliance or computer system validation (CSV) in a regulated environment (e.g. pharmaceuticals, biotechnology, CRO)
• Solid understanding of GxP regulations (incl. 21 CFR Part 11, EU Annex 11, ISPE GAMP 5)
• Experience with GDPR, data integrity, and audit preparation
• Excellent organizational and communication skills with attention to detail
• Fluent English (German is an advantage)