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. 

Requirements

  • 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.
  • Leadership.
  • Analytical skills.
  • Ability to convince others.
  • Strong communicator.
  • Ownership.

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