M&S Quality Assurance Manager - IFB (Biopharma)

Location: Beijing, China

Company

hirify.global is developing a large, automated biologics facility for insulin drug substance manufacturing in Beijing.

What you will do

• Ensure project execution follows hirify.global standards, Good Practices, GMP requirements, and applicable regulations.
• Support the IFB quality management system and the commissioning, qualification, and validation strategy.
• Prepare and execute DQ, SAT, FAT, IQ, OQ, and nP-PQ protocols, final CQ reports, and the VMP.
• Conduct quality oversight, draft, review, and approve project documentation, and ensure consistent turnover packages.
• Track quality-related project costs and progress while supporting schedule and compliance controls.
• Act as the quality SME, communicate and escalate risks, mentor project members, and promote continuous improvement.

Requirements

• Degree in science, pharmacy, or an equivalent field; an MSc-level qualification is preferred.
• 3–5 years of industry experience, preferably in biopharma or another health-regulated industry.
• Practical experience in quality operations, quality system management, and quality risk management.
• Knowledge of pharmaceutical manufacturing, production processing, automation, biologic product license applications, and regulatory requirements.
• Knowledge of GxP, FDA and international requirements, continuous improvement management, scientific and technical writing, and risk analysis.
• Strong communication, decision-making, leadership, negotiation, influencing, and cross-functional collaboration skills.

Culture & Benefits

• Supportive, future-focused environment centered on scientific progress and continuous improvement.
• Opportunities for career growth through promotion or international and lateral moves.
• Rewards package recognizing individual contribution and impact.
• Healthcare, prevention, wellness, and family support benefits.
• At least 14 weeks of gender-neutral parental leave.