For the Quality Assurance Department of our Belgian site located in Braine-l’Alleud, we currently have an opening for an experienced Quality Operations and Cleaning Manager - Early Phase & Validation.

The key tasks are:

To manage the Quality Operations & Cleaning, Early Phase & Validation  activities at the Brain Site of PolyPeptide in order to meet the Quality Unit objectives, regulations and customer expectations.

Operations:

• Organize, manage and participate in QA activities from early-phase API manufacturing to Process Validation and Cleaning Activities, including:
• Review and approval of the documentation linked to quality agreements, process optimization & validation, analytical, operations and cleaning documentation to comply with the cGMP or other legislation, with Polypeptide Quality System and customer requirements
• Management and approval of change controls, CAPAs & deviations and participation in on-line problem solving with other departments
• Release of API batches

GMP and Quality:

• Work with counterparts from Strasbourg and other sites to establish common (best) practices in quality related systems, policies and procedures
• Recommend changes in practices to enhance the conformance to GMP within all departments
• Perform internal and external audits as required

Hygiene, Safety and Environment:

• In collaboration with safety department, ensure proper training of personnel in place in order to prevent risk of accident or failure during operations.

People management and team spirit:

• Plan and prioritize the activities of the direct reports to minimize the production disturbance, meet the planning objectivies as well as the Quality and Regulatory expectations
• Ensure that the required and continuing training of the Quality Operations and Cleaning team is carried out and adapted according to needs
• Motivate, listen to and manage the personnel, maintaining a sound work spirit and discipline
• Implement “empowerment” and “full management” ways of life throughout the organization
• Evaluate annually the direct reports
• As an employee and Manager at PolyPeptide you have the duty and responsibility to develop your own and your teams competences and skills of how and why to work efficiently and effectively.
  
• You are entitled to carry the human spirit and the fundamental values of PolyPeptide.
• You are required to actively participate and support the development of your team and cross-functional work, adapting to organizational and process changes.

What we expect from you is:

• Master in Sciences with minimum 5 years experience in QA (GMP Environment and People management)
• Fluency in French and English is mandatory (spoken and written English)
• People manager and ability to work by project team
• Strong Knowledge in Chemistry
• High organizational skills, good interpersonal skills, flexibility in tasks and schedules 
  
• Sense of responsibility, enthusiasm, diplomacy and team spirit

Why you should apply

At PolyPeptide, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients and customers. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, excellence and trust. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

What we offer is :

• a full time contract  
• an attractive salary  
• extra-legal benefits and insurances
• a company car and fuel card
• a challenging position in an innovative and dynamic work environment with an open culture.