Manager Quality Monitoring Development

Job description

Ref: MEC 179

This position can also be located in LEIDEN. Some travel will be required. 

As a Manager Quality Monitoring Development, 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.

Requirements

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