Major responsibilities

• Manage projects within Quality management: ensue end-to-end project lifecycle management, including defining scope, objectives, stakeholders, and success criteria; creating schedules, budgets, resource, risk, and quality plans; leading execution across teams deliver compliant outputs; monitoring progress, managing changes, mitigating risks, and reporting status; and closing projects with outcome validation, handover, lessons learned, and resource release
• Coordinate across Quality Functions for CMC projects: Act as the single point of contact and partner closely with CMC PMs for projects involved Quality Functions.
• Quality governance and decision enablement: Establish phase‑appropriate governance (charters, RACI, cadence); prepare and facilitate for meetings that enable timely, risk‑based decisions, clear accountability, and effective escalation to senior leadership.
• Risk management and issue resolution: Proactively identify risks spanning process, analytical, supply chain, compliance, and GMP operations for cell therapy projects; maintain risk registers and drive mitigation plans
• Quality Compliance: Ensure documentation, data integrity, and procedural controls meet internal standards and evolving global regulatory expectations for Quality projects.
• Stakeholder reporting and leadership engagement: Provide structured, periodic updates across departments and to senior management; deliver dashboards, risk/mitigation summaries, and recommendations to inform decision‑making.
• Budget and timeline oversight for Quality scope: Forecast and manage Quality‑related budgets and schedules.

Education, Qualifications, Skills and Experience

• Education: Master’s degree or above in Biopharmaceuticals, Biotechnology, Pharmaceutical Sciences, Bioengineering, Chemistry, or Biology. Graduates from 985/211 universities or reputable overseas institutions are preferred.
• Language and communication: Excellent English (spoken and written); able to communicate fluently with overseas teams and author high quality English documentation. Chinese proficiency beneficial for domestic coordination.
• Experience: 3+ years of pharmaceutical project management with familiarity across CMC development processes. Direct project experience in cell therapy is a strong plus.
• Quality and GMP expertise: well understanding of GMP quality systems, data integrity, validation/qualification, change control, deviation/CAPA, supplier/CMO oversight, and inspection readiness aligned to global expectations (FDA/EMA/NMPA, ICH).
• Program leadership and governance: Proven ability to lead end to end lifecycle management (planning, progress tracking, risk control, resource coordination) and establish phase appropriate governance, RACI, and cadence to enable timely, risk based decisions.
• Cross functional coordination and stakeholder management: Strong interdepartmental coordination skills and experience collaborating with international partners.
• Problem solving and resilience: Demonstrated issue resolution capability, maintains performance under pressure and thrives in a fast paced environment.
• Operational excellence: Track record of process optimization, standard work, and use of digital/metrics tools to improve efficiency, cycle time, and right first time outcomes.
• Tools and systems proficiency: Familiar with project management tools (e.g., MS Project, Smartsheet, Jira) plus data visualization (Power BI, Tableau).
• Certifications (preferred): PMP/Prince2, Lean Six Sigma (Green/Black Belt), and/or ASQ quality certifications; formal GMP/ICH training recognized.