Manager Quality Monitoring Research - Belgium
As a Manager Quality Monitoring Research, you will be responsible for implementing the “pro-active quality principles” throughout the Research organization (i.e. from Target Discovery through Pre-Clinical Candidate Declaration) by providing continuous support and input during the project team meetings and respective sub team meetings. In this role, you will be responsible for
- Developing project specific compliance monitoring programs contributing to document / data accuracy and ultimately resulting in “PCC acceptability” by the Development stakeholders.
- Providing continuous compliance support by acting as an internal adviser on relevant procedures and guidelines to ensure correct interpretation and implementation to mitigate compliance risks.
- Building collaborative working relationships with cross-functional peers. Assists in driving change to build a culture of compliance throughout the Research organization.
- Ensuring adequate communication within the Project Teams and respective sub-team.
- Conduct audits within the Research as per applicable Master Audit Plan and work with the respective stakeholders in order to properly implement Corrective and Preventative Actions.
- Identifying areas for improvement based on Quality Monitoring activities and audit findings.
- Leads / contributes to Research specific Regulatory Authority Inspections
The ideal candidate for this job has
- Masters degree in a scientific discipline or equivalent of education and experience
- More than 10 years experience in the Pharmaceutical or Biotechnology industry with a minimum of 5 years in a Quality Management
- Current and strong knowledge of Discovery processes and Good Scientific Practices
- Auditing and Regulatory Authority inspection experience
- Demonstrates strong customer focus, organizational awareness and aims to create win-win situation with partners. Sense of urgency.
- A strong personality, a high degree of flexibility, assertiveness and excellent communication skills are essential to success.
- Proficiency with MS Office, MS Project, SharePoint, etc…
- Ability to present complex issues in a way that is understandable cross-functionally and at all levels of the organization
- Excellent problem solving, and analytical skills, including knowledge of root cause analysis tools / methodologies
- Strong interpersonal skills resulting in an effective (intra- and cross departmental) team player
- Proficient in English/Dutch/French