ASIT biotech is a Belgian clinical stage biopharmaceutical company focused on the development and future commercialization of a range of breakthrough immunotherapy products for the treatment of allergies. Thanks to its innovative ASIT+TM technology platform, ASIT biotech is currently the only developer of AIT product candidates consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection. This innovation results in a short treatment, expected to improve patient compliance and real-life effectiveness. ASIT biotech’s product pipeline entails two novel ASIT+™ product candidates targeting respiratory allergy with the highest prevalence (i.e. grass pollen: gp-ASIT+TM and house dust mite: hdm-ASIT+TM), that could significantly expand the current immunotherapy market. The Company believes that its innovative ASIT+™ platform is flexible and would be applicable across a range of allergies.
ASIT biotech has a headcount of 25 staff members, located in Liège, Belgium.
The Head Quality Assurance & Regulatory Affairs (QA/RA) lead and drive the execution of ASIT global regulatory and quality assurance strategy. He / She is responsible for regulatory affairs, quality assurance, and compliance activities and functions across all department of the Company. The Head Quality Assurance & Regulatory Affairs defines and ensures the implementation of overall quality and regulatory policies in accordance with applicable directives, guidelines and other legal requirements and current industry best practices.
Reports directly to Chief Executive Officer.
- Define and execute the QA/RA activities to support business unit and corporate strategy; and responsible for keeping the Executive Management Team informed of regulatory status and significant regulatory issues,
- Provide counsel, training, and interpretation of the regulatory authorities (EMA, FDA,…) feedback , policies, and guidelines,
- Establish, manage and maintain compliance with other global regulatory standards,
- Develop and maintain external relationships with key opinion leaders, and regulatory officials,
- Act as the point of contact for all regulatory communication in the company,
- Provide leadership and direction to the Quality team; Grows and develops the teams to meet evolving regulatory needs; is accountable for Quality Assurance and Quality Control,
- Manage recall decisions in conjunction with the Executive Management Team,
- Ensure the implementation of procedures and specifications affecting product quality,
- Ensure that a robust training GxP training program is developed and administered,
- Provide expert technical knowledge in quality assurance in support of departmental and cross functional project objectives,
- Ensure that all activities are conducted in compliance with any pertinent regulatory requirements, and in accordance with scientific standards, ethical and professional values, Management philosophy, established priorities, safety policies and practices of the company,
- Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization,
- Collaborates cross-functionally with internal departments on strategy and implementation of quality principles and regulation requirements,
- Manage internal and or external resources to accomplish the responsibilities of the role.
- Master degree or PhD in a Life Science Discipline or equivalent experience, with fifteen (15) years’ experience in Quality Assurance and/or Regulatory Affairs, including having management experience leading team,
- At least five (5) years’ experience in management Regulatory Affairs/Quality Assurance at a biotech, medical device or pharmaceutical company,
- International regulatory and quality experience is required,
- Progressive experience in the cell processing industry required; experience working in a fast-paced biotech environment preferred,
- Track record in developing and managing GxP Quality Systems through clinical phases of development to product approval,
- Thorough knowledge of ICH guidelines, GxP and related regulatory guidances,
- Proven track record of building and maintaining strong relationships with internal and external stakeholders,
- Ability to maintain multiple projects and meet timelines,
- Track record of effective business process improvements and systems implementation, including strong change management skills,
- Excellent communication and interpersonal skills; able to communicate with variety of audiences and collaborate effectively with a variety of internal and external stakeholders.
- Familiar with MS Office solutions,
- Fluent in French and English.
- To join a company with a very high growth potential,
- To integrate a very competent and motivated team,
- To collaborate to the development of innovative products in a very dynamic environment,
- Attractive salary and benefit package.