Senior Quality Project Lead - NPD & Transfer

Cytiva; Hoegaarden; Sur place; EUR 75 000 - 95 000; Plein temps

Résumé du poste

Cytiva in Hoegaarden, Belgium is seeking a Senior Quality Project Engineer to lead quality across NPD, product sustainment, customization and transfer of work.

You will be a core member of cross-functional teams, ensuring quality, regulatory and compliance requirements are integrated throughout the product lifecycle and reporting to the Director QA – Single Use Technologies, Projects and Continuous Improvement.

Qualifications

• Master or bachelor’s degree in applicable field or equivalent by experience in Quality in GMP/ISO regulated environments.
• Experience in validation/qualification and project management is required.
• Knowledge of ISO9001 and/or ISO13485 regulatory standards.

Responsabilités

• Provide quality oversight during design transfer, process development, verification, validation, and commercialization.
• Support transfer of products and processes from development to routine manufacturing with robust quality controls.
• Collaborate with Product Management, RD&E, Manufacturing Engineering, Regulatory Affairs, Supply Chain, and QA functions to ensure successful project execution.
• Author, review, approve, and maintain validation protocols and reports in compliance with procedures.
• Utilize investigations, CAPAs, non-conformances, and audit observations to drive continuous improvement and quality-by-design in development.

Connaissances

Quality leadership

Cross-functional teamwork

Project management

Validation/Qualification

GMP/ISO knowledge

Travel readiness

Formation

Master's degree in relevant field

Bachelor's degree in relevant field

Description du poste

Cytiva in Hoegaarden, Belgium is seeking a Senior Quality Project Engineer to lead quality across NPD, product sustainment, customization and transfer of work.

You will be a core member of cross-functional teams, ensuring quality, regulatory and compliance requirements are integrated throughout the product lifecycle and reporting to the Director QA – Single Use Technologies, Projects and Continuous Improvement.