Senior Quality Project Lead - NPD & Transfer

Cytiva; Hoegaarden; On-site; EUR 75,000 - 95,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Quality leadership

Cross-functional teamwork

Project management

Validation/Qualification

GMP/ISO knowledge

Travel readiness

Education

Master's degree in relevant field

Bachelor's degree in relevant field

Job description

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.