In this role you are responsible for overseeing and managing all quality-related activities. You are responsible for the Benelux quality team, where you manage the 3 Quality Managers. There are 10 teammates working in the quality team in the Netherlands and 10 in Belgium. The teams are spread over 4 sites, 2 in the Netherlands and 2 in Belgium. Together with these teams, you ensure the further structuring and professionalization of the quality policies and systems within our organization
In this position you report to the Managing Director Benelux.
Responsibilities/tasks
In this role you are responsible for:
· Responsibility for overall quality assurance at Movianto Benelux;
· Advise Benelux management on quality matters;
· Creating synergy and uniformity for QE in the Benelux;
· Directly manage 3 Quality Managers (1 NL and 2 BE);
· Maintaining and improving the functionality of the company-specific quality management system;
· Collaborate in the further development and improvement of the European and global quality management system;
· Realisation of the requirements according to the valid DIN EN ISO 9001, 13485 and 14001;
· Maintaining the certification requirements in all areas of the company and promoting awareness of customer requirements throughout the organisation;
· Compliance with the applicable regulations – local pharmaceutical laws, GDP and GMP guidelines;
· Defining the quality strategies for the region and adapting these strategies to the Group’s international quality strategies;
· Implement all necessary organisational policies of the Benelux region that are valid for the Group’s global policies and procedures;
· Regularly inform the management about quality issues;
· Work closely with the Quality Director on all matters related to IT validation within Movianto;
· Identification of weaknesses in the quality process and/or quality performance and initiation of improvement projects together with all responsible Quality Directors/Managers of the respective countries;
· Leading the review of compliance with internal quality and risk management standards in the Benelux region;
· Participation in European and global projects;
· If required, further development and implementation of additional quality management systems/updates (e.g. ISO 45001, etc.)
· Planning the annual training requirements in cooperation with Operations, as well as carrying out the effectiveness review, including the annual GxP training courses;
· If required, participation in site inspections in the Benelux region (clients, authorities, etc.);
· Coordination of the execution of all external audits in the Benelux region (supplier audits);
· Review and evaluation of measures resulting from deviations;
· Ensuring compliance of change control with regulations and customer requirements;
· Implementing and adhering the self-inspection/audit programme;
· Advise the Managing Director on correct application of environmental legislation;
· Oversee and manage environmental sustainability programs to reduce the organization’s environmental footprint. This includes energy savings, waste reduction, water efficiency and sustainable sourcing of materials;
· Promote social responsibility within the organization, by addressing issues related to employment practices, diversity and inclusion, human rights and anti-corruption principles;
· Assess sustainability-related risks and develop strategies to mitigate them;
· Evaluate the impact of climate change, regulatory changes and other sustainability risks on the organization;
· Actively participate in quality and environmental management and ensure adequate reporting/escalation;
· Continuously monitor and evaluate the organization’s sustainability performance against established KPIs and objectives. Make adjustments and improvements if necessary.
