For our client, a company in the pharma/biotech branche, we are looking for a Director Quality & Regulatory Compliance based in or near Utrecht.
The Director will be responsible for managing the Quality Management System including (but not limited to) ensuring effective management reviews, EHS compliance, customer complaint handling, CAPA system, change control, calibration maintenance, internal/external auditing and project management.
- Leads continuous improvement efforts in quality systems and department infrastructure through the evaluation of trends in key performance indicators, audit feedback, and corrective and preventative actions.
- Accountable for managing the sites' risk management, ensuring that procedural documents are available and updated, and ensuring that end-users are trained adequately.
- Represent QAU in site management teams and continuous improvement initiatives. Ensures the evaluation, trending, and communication of quality data and information for management review.
- Oversees the performance of all deviation investigations, root cause analyses; ensures robust corrective actions are identified and implemented.
- Ensure that KPI/metrics are reported out of the risk management tracking tool to senior management and local management teams.
- Provides support for the oversight of site validation activities.
- Oversees the support for Quality Systems and maintains the appropriate level of customer service. Prepare, host and respond to findings for external client audits.
- Provide, create, maintain and track all safety/health related training for all employees which includes but not limited to training, licenses, and certifications.
- Effectively lead an internal team to achieve EHS and Risk Management goals. Partner closely with internal employees, secure support, inform the facility of safety complaints.
- Collate and share information / data across the site as appropriate through reports and follow up on identified improvement opportunities.
- Actively contribute to the success of the global QA teams and the sites.
- Actively participate and/or drives EU/Global QMS improvements as required.
- Bachelor's Degree in a Scientific/Technical field is required (i.e. Chemistry, Biology, Veterinary Pharmaceuticals, and Environment, Engineering or a related field of study.)
- 5~7 years' or more experience in a related field.
- Dutch native and Fluent in English.
- Strong knowledge of Life Science research and development processes and regulatory environments.
- Strong knowledge of local laws, investigation methods.
- Excellent communication, interpersonal and teambuilding skills.
- Proven ability to work effectively with all levels in a matrix organization. Demonstrated ability to handle multiple priorities and use sound judgment. Exceptional project management and problem solving skills.
- Analytical ability is required to make competent decisions based on a review of analytical data.
- Strong Knowledge of QMS software.
What do we offer
- 1 year contract (direct hire by client) with the intention to extend this to a permanent contract.
- Start date: ASAP
- An international environment where you can learn a lot in challenging projects
When interested please react through the application process with your English resume.
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