Quality Monitoring Development Manager
Benson & Winch is looking for a Manager Quality Monitoring Development to join on a permanent basis a leading Biotech company active in discovery and development of small molecule therapies.
Please note that you can be based in Mechelen, Leiden or Romainville.
In a nutshell:
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.
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.
Masters degree in a scientific discipline or equivalent of education and experience
At least 10 years experience in the Pharmaceutical or Biotechnology industry with preferably 5 years experience in a Quality Management
Fluent in English. Speak Dutch and/or French is a big plus
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
This description matches your profile and expectations?