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Quality Systems Manager

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Bio-Pharma/Biotech - South of Brussels

Our client is a fast-growing company that provides immunology-related analytical services to pharmaceutical and biotech companies internationally.

The company is based in the South of Brussels. To strengthen the team, we are currently looking for a (m/f):

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Quality Systems Manager

Responsibilities:

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.
Profile:
  • 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.
Offer:
  • 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.
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Your application and related information will remain strictly confidential.

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