Sr. Manager, CMC QA (Biotech)

TL;DR

Sr. Manager, CMC QA (Biotech): Quality management of CDMO/CMO related to project development, technology transfer, process validation, and production with an accent on on-site supervision, review of protocols, specifications, and release data. Focus on participating in audits, managing deviations/CAPA/risks, implementing MAH quality system SOPs, and ensuring compliant commercial production.

Onsite at Yinhai Technology Innovation Center, 501 Fucheng Road, Shanghai, China

Company

Biopharmaceutical company developing differentiated novel therapeutic candidates to address unmet needs in oncology.

What you will do

• Provide on-site supervision for CDMO/CMO project development, technology transfer, process validation, and production.
• Review materials/product specifications, manufacturing processes, protocols, and reports (e.g., validation, qualification).
• Handle acceptance of release data and preliminary review of deviations, changes, CAPA, risk assessments, and lab investigations.
• Participate in quality audits of CDMO/CMO partners.
• Archive and manage product technical documents; improve MAH quality system SOPs for compliance.
• Manage technical documentation for commercial products and oversee compliant production.

Requirements

• Familiar with pharmaceutical quality management system; at least 5 years pharmaceutical QA + 2 years QC (chemical testing, experiments).
• Experience handling on-site inspections from partners and health authorities.
• Excellent communication skills in English.
• Bachelor degree or above in pharmacy or related fields.

Culture & Benefits

• Competitive base salary, bonus, equity plans, and long-term incentives.
• Up to 15 vacation days and 12 sick days annually.
• Excellent medical coverage, social security, and provident fund.
• Action-oriented, collaborative environment valuing problem-solving, accountability, adaptability, and emotional intelligence.