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

Location: Beijing, China; onsite role

Company

hirify.global is developing a large, automated and state-of-the-art insulin drug substance facility in Beijing, China.

What you will do

• Ensure project execution follows hirify.global standards, Good Practices, current GMP, and applicable local and global regulations.
• Support the IFB quality management system and the commissioning, qualification, and validation strategy.
• Assist with DQ, SAT, FAT, IQ, OQ, and nP-PQ protocols, final CQ reports, and the validation master plan.
• Conduct quality oversight, including drafting, reviewing, and approving project documentation and turnover packages.
• Manage quality risk deliverables, reporting, communication, and escalation across cross-functional project teams.
• Act as the project quality assurance SME while mentoring team members and supporting continuous improvement and digital transformation.

Requirements

• Degree in science, pharmacy, or an equivalent field; an MSc in science 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, production processing, and automation.
• Experience with quality risk management, quality systems, continuous improvement, GxP, FDA, and international requirements.
• Strong scientific and technical writing, communication, decision-making, negotiation, influencing, and cross-functional collaboration skills.

Culture & Benefits

• Supportive, future-focused environment centered on science and continuous progress.
• Opportunities for promotion, lateral development, and international career growth.
• Rewards package recognizing individual contribution and impact.
• Healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.