QA Project Deputy Director

Responsibilities

• Lead the validation management for new plant construction projects, including drafting and managing the master validation plan
• Manage validation activities performed by third-party service providers
• Coordinate resources to ensure validation implementation meets project timelines
• Review and approve User Requirement Specifications (URS), validation protocols, and reports for drug substance plant expansions, facilities, and equipment
• Review and approve URS, protocols, and reports for computerized systems, such as weighing and labeling systems
• Handle validation-related quality events, including deviations, changes, and CAPAs
• Support the execution of factory validation activities and the optimization of the validation system

Requirements

• Bachelor's degree or higher in Bioengineering, Biotechnology, or a related pharmaceutical field
• 15+ years of experience in biopharmaceutical quality management (10+ years required if holding a Master's degree)
• Proven experience in validation for new antibody drug manufacturing plants
• Extensive experience in computerized system validation (CSV)
• English proficiency (CET-4 or above) with strong listening, speaking, reading, and writing skills

About the Company

BioNTech is a leading biotechnology company pioneering novel therapies for patients, with a focus on developing next-generation immunotherapies.