Quality PM

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.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.