Quality Monitoring Lead CMC (GMP) - Mechelen, Leiden
As a Quality Monitoring Lead CMC (GMP), you will be responsible for implementing the “pro-active quality principles” throughout the Development organization (i.e. CMC, Pre-Clinical Safety, Clinical Development Partners, etc....) 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 compound specific compliance monitoring programs contributing to document / data accuracy and ultimately resulting in “dossier acceptability” by the respective stakeholders.
- Providing continuous compliance support by acting as an internal advisor on relevant procedures and regulations 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 Development organization.
- Ensuring adequate communication within the compound-specific Project Teams and respective sub-team.
- Collaborating with the Quality & Compliance Lead (development) with regards to audit programs by independent auditors. Assists the business stakeholders to ensure proper CAPA formulation.
- Leads / contributes to compound specific Regulatory Authority Inspections
- Identifying areas for improvement based on Quality Monitoring activities and audit findings.
If you are interested in joining a dynamic, open-minded, fast paced, exciting working environment, Galapagos offers you a competitive package.
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 preferably 5 years experience in a Quality Management
- Current and strong knowledge of Development processes and GXPs and regulatory requirements
- 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