QP/QA Director

Cenexi; Eigenbrakel; Vor Ort; EUR 160.000 - 190.000; Vollzeit

Zusammenfassung

Cenexi is seeking a QA/QP Director to lead all quality-related activities at its Braine-l'Alleud site south of Brussels. You will oversee QA, QC, release activities and validation, ensuring GMP compliance and effective interaction with health authorities and customers.

The role demands strong leadership, strategic budgeting, and a passion for continuous improvement in a CDMO environment.

Qualifikationen

• QP number required for the role.
• Minimum 10 years' experience in a similar position, ideally with a CDMO.
• Fluency in English and French is required.

Aufgaben

• Define the plant's Quality Policy in line with pharma regulations and customer contracts.
• Monitor regulatory changes and implement new directives.
• Lead the Quality team, ensuring it is trained, resourced and efficient.
• Approve and monitor key quality indicators and budgets.
• Participate in inspections and customer audits.
• Ensure cGMP compliance for batches and releases.

Kenntnisse

Leadership

Team management

Communication

Customer service

Critical thinking

Jobbeschreibung

Cenexi is a contract development and manufacturing organization (CDMO) that has quickly built a reputation for excellence based on its sterile expertise, innovation and high quality products.

The Braine-l'Alleud site is located 20 km south of Brussels and employs 300 people. The site is specialized in the manufacture of highly active sterile injectables, mainly for cancer treatments.

The Group is positioned in the highly active international market for drugs with major therapeutic indications, drawing on its spirit of innovation and expertise. It is one of Europe's leading manufacturers of sterile and injectable products (70% of current sales, 80% projected within 3 years), with a growing proportion of biological products.

MAIN ACTIVITIES

As QA/QP Director, you will manage and be responsible for all Quality-related activities at the site: Quality Assurance, QA Operations, Quality Control (QC), release activities and validation, in compliance with the various procedures and rules (quality, safety, health and environment). You will also be responsible for behalf of our customers and health authorities.

As Responsible Pharmacist (N° QP), you are the guarantor, for the Belgian Health Authorities, of the application of GMP and pharmaceutical regulations in force.

As such, you are responsible for the pharmaceutical management of the site, including the production plant and the R&D center.

This strategic position reports to the Site General Manager and is part of on the Site Leadership team Committee.

Your main tasks are :

Operational management & steering of quality processes

• Define, in collaboration with site management, the plant's Quality Policy in line with current pharmaceutical regulations and those defined for our customers ;
• Monitors changes in regulations, and supervises the implementation of new directives ;
• Supervises the Quality team, ensuring that it is complete, trained and efficient, and carries out the tasks and action plans assigned to it in order to achieve the objectives set ;
• Supports the Business in providing high quality quality processes, and ensures their implementation, within established budgets.
• Participates in site continuous improvement projects ;
• Suggests continuous improvement when recurring deviations ;
• Approves and monitors existing indicators relating to site activities ;
• Prepares, defends and monitors short, medium and long-term budgets and investment budgets for the Quality Department.

Audits / Communication / Customer management

• Ensures professional relations with authorities ;
• Participates in inspections by authorities and customer audits ;
• Act as a relay with customers on quality-related issues.

Batches Release (Responsible Pharmacist)

• Guarantee that each batch of medicines has been manufactured and controlled in accordance with cGMP (Eudralex Volume §4; Appendix 16) and, where applicable, the marketing authorization in accordance with the contracts / "Quality Agreements" drawn up with customers.

REQUIRED PROFILE

Qualifications and experience required

• QP number ;
• You have at least 10 years' experience in a similar position (ideally with a C(D)MO) or knowledge of C(D)MO specificities is a plus)) ;
• Fluency in English/French is required (most customers are English-speaking).

Softskills and personal skills

• Thanks to your leadership skills, you can help teams achieve their objectives, and you have proven experience in team and department management (+/- 50 HC) ;
• Excellent communication skills and a keen sense of customer service. You are solution-oriented and encourage collaboration between teams ;
• Demonstrate critical thinking, analytical skills, proactivity and initiative ;
• Share Cenexi's values: team spirit, agility.