Quality Assurance Expert (IFB)

Location: Beijing, China

Company

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

What you will do

• Ensure project execution complies with hirify.global standards, Good Practices, GMP, and applicable local and global regulations.
• Support the IFB quality management system and commissioning, qualification, and validation strategy.
• Prepare and execute DQ, SAT, FAT, IQ, OQ, and nP-PQ protocols, final CQ reports, and the Validation Master Plan.
• Conduct quality oversight activities, including drafting, reviewing, and approving project documentation.
• Act as the project Quality Subject Matter Expert and communicate or escalate quality risks to management.
• Support project cost and schedule tracking, quality reporting, and development of global quality procedures.

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 regulated industry.
• Practical experience in quality operations, quality system management, and quality risk management in a health-regulated environment.
• Knowledge of biologic product license applications, regulatory requirements, pharmaceutical manufacturing, and production automation.
• Knowledge of quality risk management, quality systems, continuous improvement, GxP, health-regulated requirements, and international or FDA standards.
• Good written and spoken English skills, plus strong technical writing, communication, decision-making, negotiation, and 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 contribution and impact.
• Healthcare, prevention, wellness, and family benefits.
• At least 14 weeks of gender-neutral parental leave.