Manager Quality Management Systems at HAL Allergy
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.
HAL Allergy is a modern leader in the field of biopharmaceuticals, located in the Leiden Bio Science Park in The Netherlands. Our core business is the development and manufacturing of therapies and diagnostics for allergic diseases.
With offices in major European countries, HAL Allergy is one of the European top players in the allergy immunotherapy business. Established in 1959 HAL Allergy has a long experience in developing, producing and selling allergy therapies with an immuno-modulatory effect, resulting in a reduction of symptoms and long-term disease suppression. These therapies are primarily used against common allergies such as hay fever, house dust mites allergy and allergic reactions towards wasp or bee stings.
In addition to the core business of HAL Allergy, our subsidiary HALIX was founded in 2012. HALIX is a contract development and manufacturing organization (CDMO) licensed for the contract manufacturing of clinical and commercial medicines according to GMP standards. As an end-to-end service provider, HALIX will serve its customers the full range from the first development steps to start of commercial production after successful registration of products.