M&S - Quality Assurance Manager-IFB (Biopharma)

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 follows hirify.global standards, Good Practices, current GMP, and applicable regulatory requirements.
• Support the quality management system, C&Q&V strategy, plans, and system impact assessments.
• Assist with DQ, SAT, FAT, IQ, OQ, nP-PQ protocols, final commissioning and qualification reports, and the validation master plan.
• Conduct quality oversight, including drafting, reviewing, and approving project documentation and turnover packages.
• Act as the project Quality Subject Matter Expert and communicate or escalate quality risks to management.
• Promote quality culture, continuous improvement, mentoring, and effective cross-functional collaboration.

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.
• In-depth knowledge of biologic product license applications and associated regulatory requirements.
• Practical experience in quality operations, quality system management, and quality risk management in a health-regulated industry.
• Knowledge of pharmaceutical manufacturing, production processing, automation, scientific and technical writing.
• Experience with GxP, health-regulated requirements, international regulations, and FDA requirements.

Culture & Benefits

• Supportive, future-focused environment centered on scientific innovation.
• Career development opportunities through promotion and international or lateral moves.
• Rewards package recognizing individual contribution and impact.
• Healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.