Director QA HALIX at HAL Allergy

Job purpose

HALIX delivers end-to-end bioscience services for therapeutic proteins, viral vectors and vaccines. The QA director is leading the quality operations to ensure compliance with EU and FDA directives and is ultimately responsible for the release of clinical trial materials or commercial batches.

The QA director will represent and communicate the quality policies and performance to authority bodies, customers and business partners and ensures corresponding alignment in the company.

Responsibilities

  • Performance of the quality operations consisting of QP’s, quality assurance and quality control teams.
  • Implementation of quality policies in project management, development, manufacturing and quality operations.
  • Relationship and communication with Dutch inspectorate IGJ/Farmatec in order to maintain and update GMP permits and manufacturing licenses.
  • Audit readiness and manage GMP inspections performed by Dutch inspectorate or FDA authorities.   
  • Maintaining good relationship and communication with customers in order to negotiate quality agreements, perform audits or solve quality challenges.
  • Periodic reporting of the quality performance using key performance parameters, in line with EU/FDA quality directives and including improvement planning.
  • External auditing at service providers and suppliers as part of the vendor rating system. 
  • Service complaints or product quality complaints.

Qualifications

  • Academic degree in life sciences (e.g. pharmacy, immunology, virology).
  • Eligible as a Qualified Person by the Dutch inspectorate IGJ.
  • 10 years of experience with biotechnology and CMC manufacturing.
  • Experience with biotechnological production on clinical and industrial scale.
  • Broad knowledge and experience with EU/FDA GMP guidelines and inspections.  

Personal & Professional Skills

  • Natural authority.
  • Being able to apply situational leadership.
  • Experience with communication on all levels including with officials and Sr. management.
  • Good knowledge of English, both verbal and written. Dutch advantageous.
  • Decisive, analytical and accurate.
  • Ability to be creative, thinking out of the box.

About HALIX

Founded in 2012 as a corporate venture and spin-off of HAL Allergy, HALIX is a contract development and manufacturing organization (CDMO), based in Leiden, the Netherlands. The company is licensed for the contract manufacturing of clinical and commercial medicines according to GMP standards. HALIX leverages advanced biopharmaceutical technologies and provides the full portfolio of pharmaceutical documentation of GMP production processes, as well as production of units which are required for clinical approval. HALIX, as an end-to-end service provider, will serve its customers the full range from the first development steps to start of commercial production after successful registration of products. More information is available on: www.halix.nl.

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