IFB-Quality Assurance Manager-QMS (Biologics)

Location: Beijing, China

Company

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

What you will do

• Lead the development, implementation, and assurance of quality management systems for the project and future site.
• Act as the quality management system subject matter expert and ensure compliance with GMP, hirify.global standards, local regulations, and approved documentation.
• Write, review, and release quality documentation, global quality procedures, and related project deliverables.
• Support raw material activities, third-party manufacturing, and cross-functional project planning and reporting.
• Support the C&Q&V strategy, system impact assessments, turnover packages, and review or approval of validation protocols and final reports.
• Track project costs and progress while escalating quality issues and supporting schedule compliance.

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 related regulatory requirements.
• Practical experience in quality system management within a health-regulated industry and knowledge of pharmaceutical manufacturing, including automation.
• Experience in scientific and technical writing, with strong communication, decision-making, negotiation, and cross-functional collaboration skills.
• Fluent Chinese and English, both written and spoken, are required.

Nice to have

• Experience with CapEx project execution and project quality management.
• Experience in driving change, people development, business partnering, and leadership.

Culture & Benefits

• Work alongside a supportive, future-focused team bringing scientific innovation to life.
• Access career development opportunities through promotions and lateral moves, locally and internationally.
• Receive a rewards package designed to recognize contribution and impact.
• Health and wellbeing benefits include healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave is provided.