Our client is a fast-growing company that provides immunology-related analytical services to pharmaceutical and biotech companies internationally.
The company is located 50km South of Brussels. To strengthen the team, we are currently looking for a (m/f):
Quality Systems Manager
Reporting to the Quality Assurance Director, you are responsible for maintaining and enhancing the Quality Systems. You will oversee and manage Quality Assurance activities, ensuring GLP, GCP, GCLP, ISO/IEC 15189 Quality Processes, Training and Qualification.
Your main responsibilities are:
- Develop, implement, maintain and enhance Quality Systems and associated procedures.
- Participate in obtaining appropriate certification or accreditation.
- Update and maintain Quality Assurance logs, databases, and generate metrics.
- Provide GxP compliance, general QA support and guidance to personnel.
- Conducts internal and external audits.
- Develop, write and review SOPs to ensure compliance with applicable regulatory and corporate standards.
- Participate in the development and delivery of internal training programs.
- Review and evaluate investigations, findings and resolutions, change control, CAPAs, non-conformances, and audit observations.
- Review CAPAs to determine effectiveness, perform trend analysis and compile summary reports.
- Report compliance risks to senior management.
- Support equipment and software validations.
- You hold a bachelor’s degree in Life Science, or equivalent through experience.
- You have 5+ years of quality and/or compliance related experience in CRO industry, working in a regulated environment with direct QA responsibility.
- You have excellent knowledge, understanding, and application of ISO/IEC 15189, GCP, EMA, OECD in relation to Good Laboratory Practice (GLP) and/or GCLP quality requirements;
- You have good knowledge in Drug Development, Validation of Analytical Methods, Quality Assurance and Regulatory Compliance, applied to various bioanalysis techniques.
- You demonstrate documentation management skills, ability to design and implement quality processes;
- You have a high level of attention to detail and accuracy, and excellent investigative techniques;
- You have strong leadership, management and communication skills;
- You are able to identify and/or resolve quality issues, discrepancies with others in a proactive, diplomatic, flexible and constructive manner;
- You are able to independently convey information with authority, handle highly sensitive matters and interact with high-level contacts within other organizations.
- A full-time permanent position within a fast-growing company.
- A dynamic, professional and stimulating work environment.
- Training and development opportunities.
- An attractive compensation package in line with the position responsibilities and your experience.