Director QA HALIX at HAL Allergy
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 ensure corresponding alignment in the company.
Tasks and 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.
- 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.
- Academic degree in life sciences (e.g. pharmacy, immunology, virology).
- 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.