Clinical Development Quality Lead
Brabant Wallon – contracting
Our partner is looking for an Clinical Development Quality Lead to join its team. This international company is well-known for its research, development and marketing of pharmaceutical and biotechnology products.
What are your responsibilities?
- Lead the development of a risk mitigation program for our client programs, prospectively identifying critical quality risk factors and their potential impact, and developing efficient processes or solutions to manage the risks
- Lead the overall Inspection Readiness process for preapproval GCP inspections or other inspections involving the clinical programs
- Support inspections and investigations conducted by international and national authorities, including responsibility for the preparation and hosting of our client sponsor sites for inspections
- Plan, coordinate and execute Clinical Development Quality activities in accordance with the risk mitigation plans to validate the systems and processes established to ensure subject safety and protection and to ensure that clinical trials performed, and data are generated in compliance with international and national GCPs
- Review and coordinate the output of trends from audits and risk analyses prepared by colleagues, providing senior management and peers in other departments with a summary and analyses of the comparative risks and outcomes across multiple clinical programs
- Ensure resolution of audit findings through close collaborations with the audit & compliance team. Utilize in-depth knowledge and understanding of current business trends, applicable regulations and quality principles, to collaborate effectively and influence approaches to quality, and ensure work products and output are aligned with regulatory guidelines, ICH-GCP, other applicable regulatory requirements and our client global quality standards
- Represent Clinical Development Quality at interdepartmental and project team meetings taking the leadership role when required, and dealing with complex and difficult or important project issues
- Deliver presentations to peers, senior management, and industry audiences, acting as a role model for change
- Helps develop, coach and mentor junior colleagues, generating enthusiasm and encouraging new ideas.
Who are you?
- You hold a bachelor’s degree in sciences or equivalent by experience
- 10 plus years of background, knowledge and experience of the (bio)Pharma industry and applicable technical aspects of the business
- 3 to 5 years previous experience on Clinical Quality within a CRO or in Pharma
- You are fluent (both written and spoken) in French and English
What can you expect?
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. Do you have any questions? You can contact Camille Pisson: [email protected]