Manager Quality Systems at HAL Allergy
The Manager Quality Systems is responsible for performing a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
Tasks and responsibilities
- Day to day management of the Quality System department.
- Interface with and support company affiliates during local and global regulatory inspections.
- Ensure that quality systems at HAL Allergy are maintained in a compliant state and ensure oversight in regulatory changes which may impact the systems.
- Ensure that the staff is properly trained for the required GxP.
- Serve as a lead of investigations, root cause analyses and corrective and preventive action (CAPA) recommendations.
- Work with Research & Development during new product start-ups and establish key checkpoints for new products and processes.
- Keeps track of developments in the areas of RA, Document Management and Quality Systems and translates these to possible challenges for the organization.
- Maintain appropriate QA oversight of (validation of) computerized systems and IT platforms to ensure continued compliance.
- Manage improvement projects from the company project portfolio.
- Review data, draw conclusions and derive meaningful improvement steps from this.
- Contributes to the project team related to implementation of IDMP regulations.
- Upon request act as Director QA in his/her absence, including management of Quality Control department.
- Masters or PhD degree.
- Minimum of 8 years relevant experience in the pharmaceutical industry, in a QA or RA role and at least 4 years in a management position.
- Advanced knowledge of GxP regulations for validation of computerized systems.
- Proven knowledge of Data Integrity in relation to both electronic & paper data.
- Experience with FDA inspections a distinct advantage.
- Broad experience with quality related issues in aseptic production.
Personal & Professional Skills
- Knowledge of regulations in pharmaceutical industry.
- Excellent command of both English and Dutch.
- People management.
- Analytical skills.
- Ability to convince others.
- Strong communicator.