Head of Quality H/F Bruxelles
Excellent opportunity with well known Bio business
Senior management position
À propos de notre client
Our client is a major bio Pharmaceuticals manufacturer based just South of Brussels who are looking for a Head of Quality.
Description du poste
Taking the leadership for Quality Operations of the well-known you will ensure the continuous supply of products in line with the business objectives to meet patients and customer needs.
Key responsibilities will include;
- Develop and operate the product quality activities and key GMP processes in line with the strategies, policies and standards of the business.
- Achieve quality performance targets, regulatory compliance and cost efficiency for QA Drug Product
- Responsible for the deployment of the strategy within your business unit
- Responsible for the leadership and operational quality management
- The scope of the quality oversight consists of formulation, filling, packaging, warehousing and expeditions
- Organise and take the full Quality Assurance responsibility for operational activities related to development and investigational medicines manufactured in the department.
- Drive a continuous Quality and Compliance improvement mind-set within the Operations environment so as to ensure compliance with cGMP's and Quality Management System.
- Ensure regulatory inspection readiness and provide QA expertise to act as a key spokesperson during external Regulatory inspection
- Ensure staff is adequate in quality and number to ensure an adequate QA oversight
- Ensure timely release of all development drug product batches manufactured in the product department
- Ensure adequate QA oversight on all production change controls both in terms of content and timeliness.
- Drive a continuous Quality and Compliance improvement mindset within the Operations environment such to ensure compliance with cGMP's and the Quality Management System.
To be considered for the role of Head of Quality, you must be able to display the following skillset
- University degree: master degree in Sciences/Engineering e.g. Pharmacist / Master in Sciences / Bio Engineer, Ideally PhD, MBA.
- 10 years of experience in a pharmaceutical environment with Substantial knowledge of GMP, manufacturing operations (aseptic practices), clinical trial, product development and regulatory requirements - experience in the start-up of new facilities is an advantage
- Excellent knowledge of sterile Pharmaceuticals guidelines and inspections.
- Strong knowledge of GMP.
- Executive and leadership capability to manage people.
- French speaker with excellent written and spoken English skills.
- Willing to be based just south of Brussels
Conditions et Avantages
An excellent basic salary in line with the Head of Quality post and a competitive package in the Bio Pharmaceuticals sector