Quality Assurance Lead for Non-Clinical Operations

Title: Quality Assurance Lead for Non-Clinical Operations

Position: Belgium 

RESPONSIBILITIES:

-  Contribute to ensuring regulatory compliance with GLP standards for the Test Facility, aligning with OECD guidelines.

- Oversee the implementation of processes and systems (e.g., facilities, equipment, personnel, methods, practices, records) in accordance with the Test Facility's GLP non-clinical program.

- Support the continuous improvement of the QMS system. Develop and/or review controlled documents (e.g., standard operating procedures, policies, CAPAs, change controls, master schedules).

- Evaluate study plans, reports, amendments, and deviations, and prepare quality assurance program statements for study plans and reports.

- Conduct inspections related to facilities, studies, and processes to ensure adherence to GLP regulatory requirements.

PROFILE:

- Hold a master’s degree in life sciences or a related field.
- Possess over 3 years of experience in non-clinical quality assurance and familiarity with GLP regulations.
- Demonstrate a robust understanding of GLP OECD guidelines and non-clinical research.
- Experience in a CRO is a plus.
- Familiarity with standard laboratory techniques, such as cell culture and molecular biology, is advantageous. .

SKILLS:

- Proficiency in written and spoken English.
- Excellent communication, organizational, and scheduling skills, with a track record of delivering projects on time.
- Approach challenges with a solutions-oriented mindset, coupled with strong problem-solving and analytical abilities.
- Ability to adapt quickly, work proactively, and operate autonomously.                    - Demonstrate teamwork and a willingness to integrate into a small, flexible structure.