Associate Manager / Senior Specialist - ASAT (Quality Control)

About the role

Roche is hiring an Associate Manager / Senior Specialist for its ASAT (Analytical Sciences and Technology) function in Shanghai. The role ensures that the quality and regulatory compliance of products made at the Shanghai site are met through effective management of quality control system functions, while applying best practice such as GMP and GLP in the laboratory.

Key responsibilities

• Manage validation, qualification, transfer and troubleshooting of analytical methods, and manage analytical trending in the labs
• Ensure pharmacopoeia compliance at site and support Chinese Pharmacopeia (ChP) compliance across the group
• Manage samples, reference standards and stability programs to support China business
• Support and execute QC activities including process and cleaning validation, special analytics, investigations and non-routine testing
• Develop and implement the new technology roadmap with other QC labs and global functions
• Maintain QC specifications and analytical methods, and keep the master method validation plan up to date
• Manage third-party QC labs, provide technical guidance on test methods, and support manufacturing operations and regulatory inspections and audits
• Generate QC metrics and reports (TCM, discrepancies, CAPA) and align CMC submissions with QC specifications

Required profile

• Bachelor's degree (biology, microbiology or biochemistry preferred); graduate or higher degree preferred
• At least 4 years of experience in the analysis of biological drug products
• Excellent spoken and written English

Required skills

• Expert knowledge of compendial test methods (ChP, USP, EP, JP)
• Knowledge of CMC regulations and cGMP
• Knowledge of pharmaceutical quality system principles and standards