M&S - Quality Control Expert - IFB (Biologics)

Location: Beijing, China; onsite role

Company

hirify.global is developing a new automated, sustainable, state-of-the-art biologics facility for insulin drug substance manufacturing.

What you will do

• Establish the Quality Control laboratory from planning and equipment qualification through final approval and transition to routine operations.
• Provide analytical expertise for projects, troubleshooting, investigations, analytical methods, and laboratory technologies.
• Create and review protocols, reports, and standard operating procedures for analytical validation, transfer, and qualification activities.
• Ensure GMP-compliant execution and documentation of quality tests, raw data, calculations, deviations, non-conformities, and corrective actions.
• Lead internal and external analysts and technicians, providing training, mentoring, coaching, and development.
• Manage laboratory project delivery against budget, schedule, performance, HSE, quality, and hirify.global standards while collaborating with Frankfurt, MSAT, and global subject-matter experts.

Requirements

• Degree in Chemistry, Pharmacy, Biochemistry, or an equivalent field; an MSc or PhD is preferred.
• At least 5 years of pharmaceutical or biotechnology industry experience, preferably including analytical method transfer or verification and instrument qualification or validation.
• At least 2 years of project leadership experience with a record of delivery and compliance.
• In-depth understanding of GMP principles, data integrity, health-regulated requirements, and international or FDA requirements.
• Experience with analytical techniques and software, plus scientific and technical writing.
• Proficiency in English, German, and Mandarin across listening, speaking, reading, and writing is required.

Nice to have

• Knowledge and experience with PAT, automation, or LIMS.
• Strategic planning, risk analysis, negotiation, influencing, and change-management experience.

Culture & Benefits

• Work in a large global and cross-functional program organization.
• Collaborate with the Frankfurt sending unit, MSAT, and a global subject-matter expert network.
• Operate according to cGMP, HSE, regulatory, and internal quality standards.
• Support occupational safety through risk assessments, communication, and training.
• Drive operational standardization, cost management, and continuous improvement.