Global Director Quality (NL)

We are looking for an entrepreneurial Global Director Quality. In this position you are responsible for managing and further developing Quality Assurance and Quality Control within Symeres. This includes managing the QA/QC departments at the API GMP manufacturing sites in the Netherlands (Weert) and Czech Republic (Prague). Besides, with R&D sites across EU and the US as well as GMP manufacturing of Drug Product in the US, the Global Director Quality will be responsible for setting up and maintaining a coherent global Quality Assurance and Quality Control framework covering all activities of Symeres. You will ensure the implementation and execution of the global quality policy and drive compliance and continuous improvement of the global and local quality management systems. Additionally, you are accountable for the governance of Quality Oversight within Symeres.

Position in organization

The Global Director Quality will report to the Managing Director Drug Development of Symeres.

Key job responsibilities:

• Manages the Quality Teams of the different sites

• Drives the development of global Quality processes and quality improvement programs

• Contributes to operational and strategic decision-making

• Ensures cGMP performance is measured through KPIs and compliance metrics

• Ensures compliance of global and site-specific quality systems with applicable laws and regulations and actual and future customer demands, including periodic review of this

• Leads regulatory inspections of health authorities and supports internal audits, and external audits from customers

• Is advisor/specialist/coordinator/trainer for the sites with respect to quality/cGMP/CVS

• Works closely with internal stakeholders (such as operations, supply chain, engineering and business development) and external partners including customers and health authorities

• Deals efficiently with critical incidents, deviations and customer complaints

• Controls changes in processes to stay in compliance with laws and regulations, customer demands and product registrations

Qualifications

• A Master’s degree, preferably in Pharmacy or Life Sciences

• At least 10 years of relevant experience in an international cGMP environment

• At least 5 years’ experience in a senior management position

• Knowledge of cGMP; expert in quality relevant regulations (e.g. ICH Q7, EU Eudralex Volume 4 regulations, 21 CFR parts 210 & 211, GAMP5, 21 CFR part 11)

• Experience in generating long-term strategic plans

• Hands on mentality, data driven decision making and result oriented

• Excellent problem-solving aptitude, communication and multi-tasking skills

• Knowledge of and insight in company- and work processes and installations

• Ability to coach, mentor, develop and train employees

Job offer

An exciting position in a dynamic organization with an attractive remuneration package and opportunities for learning and development.