Solutions Quality Lead
Contracting – Brabant Wallon
Your responsibilities:
- Audit Management
- Conduct audits of Study Reports, Study Phase Reports, Study Plans and Study Plan Amendments to assure the applicable OECD guidelines, SOPs and the Analytical Methods have been adhered to and that reported results accurately reflect the raw data according to SOPs and associated controlled documents
- Archive audit documentation per SOPs; e.g., issued audit reports, supporting documentation, QAS, additional documents as expected according to SOPs and associated controlled documents
- Follow up with CAPA owners to manage actions to an on-time completion according to SOPs and associated controlled documents Issue Management
- Contribute to investigations of non-compliance to areas of research and development operations which are within the scope of the Good Laboratory Practice (GLP) Compliance Program, the Good Clinical Practice (Laboratory) Guidelines (GCP Lab), and relevant Human Tissue regulations according to Policies and Procedures
- When requested, facilitate discussions with internal stakeholders and SME network to develop appropriate action plans, decisions and ensure efficient actions are taken to ensure compliance to according to Policies and Procedures and OECD Principles. Inspection Readiness Support
- Provide support during GLP/GCP inspections and investigations conducted by international and national authorities or business partners according to Policies and Procedures as requested Other Responsibilities
- When requested, represent R&D and PV Quality at interdepartmental, project and study team meetings as an individual contributor
- When requested, provide guidance to other members of the R&D and Pharmacovigilance Quality team.
Your profile:
- Bachelor's degree in Sciences
- Ability to drive collaboration and engagement across the stakeholder network, motivating others to achieve results
- Skilled in influencing others within a global matrix organization and driving informed decision–making
- Capable of prioritizing and focusing on critical issues using a risk-based approach
- Manage quality and compliance issues with diligence, rigor, transparency and timeliness
- Demonstrate strong analytical skills with experience in analyzing and synthesizing complex data
- Fluency in French & English
Our offer:
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
