About this opportunity
About the Role:
As a QA Specialist in Drug Product Manufacturing, you will play a pivotal role in ensuring the quality and compliance of our drug product manufacturing processes. You will contribute to maintaining high standards of operational excellence by overseeing production activities, managing deviations, and ensuring adherence to GMP regulations. This position offers an opportunity to work in a dynamic environment where your expertise will directly support BioNTech’s mission of pioneering immunotherapies for serious diseases.
Your Contribution:
Supervise key drug product manufacturing processes, including weighing, solution preparation, vial washing, filling, capping, labeling, packaging, cleaning/disinfection, line clearance, and storage
Review and approve SOPs related to drug product manufacturing operations
Support the optimization of quality management documents for drug product production
Audit production data and batch records to ensure accuracy and compliance
Review deviations, change controls, CAPAs; participate in OOS investigations
Oversee the release of drug products and handle non-conforming materials during production
Manage clinical drug returns and ensure proper handling procedures are followed
Address product complaints, returns, and recalls effectively
Monitor environmental conditions in manufacturing areas and confirm alarms as needed
Assist with material release processes and supplier qualification related to drug product manufacturing
Collaborate on technical transfers for drug product manufacturing processes
A Good Match:
3–5 years of experience in pharmaceutical quality management or related fields; prior QA experience in drug product manufacturing is preferred
Familiarity with aseptic processing and biological drug production is an advantage
Strong knowledge of Chinese GMP regulations and pharmaceutical quality management systems
In-depth understanding of drug product manufacturing workflows and on-site quality requirements
Skilled in managing deviations, change controls, CAPAs, batch record reviews, and other quality-related activities
Excellent communication and problem-solving skills with a detail-oriented mindset; capable of working effectively in a production environment
Proficiency in English (CET-4 or above), with the ability to read technical documents and quality files
Join us at BioNTech as we strive to transform lives through innovative therapies. If you are passionate about quality assurance in pharmaceutical manufacturing and thrive in a fast-paced environment dedicated to excellence, this role is for you!
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