Manufacturing Systems Quality Partner

About the role

The Manufacturing Systems Quality Partner will join the Internal Bio & GT Manufacturing Systems Quality team, supporting daily manufacturing, validation and qualification activities in the Bio Pilot Plant (T2) and Gene Therapy building (Genesis – T4) located in Braine‑l‑Alleud, Belgium.

Key responsibilities

• Collaborate with clinical manufacturing, CMC, operations and technical services to ensure product quality, safety and regulatory compliance.
• Maintain and improve the Quality Management System, including SOPs, protocols and report reviews.
• Plan and execute compliance tours, GMP area spot‑checks and provide on‑floor QA support.
• Partner with cross‑functional teams to investigate and resolve deviations, out‑of‑specifications and change controls.
• Support qualification and validation activities for clinical manufacturing processes.
• Monitor and share key performance indicators and related extracts.

Required profile

• University degree (Bachelor’s or Master’s) in a relevant scientific discipline.
• Strong understanding of current regulatory requirements and ability to interpret them in a product development context.
• Experience in QA/compliance within drug substance manufacturing, facility operations or laboratory quality systems is an asset.
• Knowledge of the pharmaceutical biologics industry and practical GMP application.
• Excellent written and oral English communication skills.
• Ability to work autonomously with limited supervision and handle complex situations.

Required skills

• Good knowledge of GMP principles and risk‑based compliance.