QA Lead - Biopharmaceuticals (Shanghai)

About the role

Roche is hiring a QA Lead for its biopharmaceutical business in Shanghai. The role covers product release, batch documentation, aseptic batch oversight, supplier and third-party quality management, audit readiness, and annual product quality review.

Key responsibilities

• Review and approve all Batch Production and Batch Control Records, and verify test results against specifications to issue Certificates of Analysis for product release
• Oversee the local release of aseptic filling and packaging batches, including sterility assurance and environmental monitoring data
• Manage quality oversight of raw materials, consumables and primary packaging, including risk assessments and supplier qualification
• Oversight of third-party service providers and external laboratories, including Quality Agreements and audit/inspection readiness
• Lead the Annual Product Quality Review, analyse batch records, OOS results, deviations, changes and stability data, and assess CAPA effectiveness
• Ensure timely regulatory reporting of APQR (NMPA, FDA, EMA) and support investigations, audits and interactions with regulators
• Support tech transfer, compliance, regulatory and training activities, and continuous improvement of QA operations

Required profile

• Degree in pharmaceutical sciences, life sciences, biology, biotechnology, chemistry, chemical engineering or a related field
• Minimum 7 years in pharmaceutical or biotechnology quality assurance, GMP compliance, operations or validation, ideally in a multinational company
• Aseptic filling experience required; experience in the new DP facility project expected
• Fluent English and good communication skills

Required skills

• FDA/EU cGMP knowledge and thorough understanding of ICH guidelines
• Experience in new facility startup readiness and ramp-up
• Advantageous: auditor training certification