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上海市, 中国
Onsite
JOB PURPOSE
End-to-end cell therapy value chain: Discovery, Preclinical, Process Development (PD), CMC, and Manufacturing / Operations.
The ITBP is the single IT leader accountable for the digital and IT agenda of the China cell therapy business, from target discovery through preclinical, process development (PD), CMC and GMP manufacturing / operations.
Cell therapy is a living, often patient-specific product. Autologous therapies such as CAR-T link one patient's cells to one product through apheresis, manufacturing, release and infusion, so Chain of Identity (COI) and Chain of Custody (COC) are critical requirements. This makes data integrity, traceability and GxP-validated systems central to the business, not back-office support.
The role translates business strategy into a digital roadmap, owns the relationship between the cell therapy leadership team and IT, and makes sure China solutions work with global platforms, standards and partners while staying compliant with Chinese regulation (NMPA GMP, PIPL, Data Security Law, Human Genetic Resources rules).
DUTIES & RESPONSIBILITES
1. Business partnering and digital strategy
• Act as the trusted IT advisor to the Head of Cell Therapy and functional leaders in Discovery, Preclinical, PD, CMC, Quality and Manufacturing.
• Build and maintain a 3-year digital and IT roadmap for the cell therapy business, aligned to pipeline milestones (IND, clinical supply, BLA/NDA, commercial launch).
• Gather and prioritise business demand, shape business cases, and secure funding through IT governance.
• Identify opportunities in automation, data and AI (e.g. lab automation, predictive process analytics, AI-assisted target or CAR design).
2. Value-chain solution ownership
The ITBP owns the end-to-end application landscape across the value chain.
• Lead selection, implementation and lifecycle management of these systems, with vendors and internal delivery teams.
• Ensure seamless data flow across stages, so data from Discovery and PD can be reused in CMC and manufacturing (FAIR data principles).
• Support clinical and commercial readiness: patient scheduling, apheresis-to-infusion tracking, ISBT 128 labelling and integration with treatment centres and logistics partners.
3. GxP compliance and data integrity
• Ensure all GxP systems follow Computer System Validation (CSV / CSA), ALCOA+ data integrity, and NMPA, FDA and EMA expectations (e.g. NMPA GMP Computerised Systems Appendix, 21 CFR Part 11, EU Annex 11).
• Partner with Quality to prepare for regulatory inspections and audits, and resolve IT-related findings.
• Embed cybersecurity and access control appropriate for patient and manufacturing data.
4. China regulatory and data compliance
• Design IT solutions compliant with PIPL, the Data Security Law, Cybersecurity Law and CAC cross-border data transfer rules.
• Work with Legal and Compliance on Human Genetic Resources (HGR) requirements, including data location, access by overseas parties and filings for international collaboration.
• Define data classification, localisation and secure sharing models that let China teams collaborate with global R&D while staying compliant.
5. Global collaboration
• Act as the China voice in global IT and R&D digital forums; align China solutions with global platforms, architecture and standards wherever possible.
• Coordinate with global ITBPs and product owners on shared programmes, template rollouts and tech transfer between China and overseas sites.
• Enable secure collaboration with external partners such as CROs, CDMOs, academic institutes and licensing partners.
6. Delivery, vendor and budget management
• Oversee project portfolio delivery on scope, time, budget and quality, using agile or waterfall as appropriate.
• Manage local and global vendors, contracts and SLAs; build a strong local partner ecosystem.
• Own the IT budget (CAPEX / OPEX) for the cell therapy business and report on value delivered.
• Lead or coordinate a virtual team of project managers, analysts and technical specialists.
JOB REQUIREMENTS & COMPETENCIES
- Bachelor's degree in Computer Science, Information Systems, Life Sciences, Bioengineering or a related field; Master's degree preferred.
- Technical / skill training：
o Solid understanding of the cell therapy value chain, including autologous and allogeneic models, COI / COC and vein-to-vein logistics.
o GxP, CSV / CSA, data integrity (ALCOA+), 21 CFR Part 11, EU Annex 11 and NMPA requirements.
o China data regulation: PIPL, Data Security Law, CAC cross-border transfer rules and HGR regulations.
o Modern data and cloud architecture, integration and analytics; familiarity with AI / ML use cases in R&D is a plus.
- 10+ years in pharma / biotech IT, including 5+ years in a business partner, product owner or IT lead role facing R&D or manufacturing.
- Fluent in Mandarin and English, written and spoken.
Essential：
- Hands-on experience with cell and gene therapy, biologics or other advanced therapy (ATMP) businesses strongly preferred.
- Proven track record delivering GxP systems such as LIMS, ELN, MES, QMS or cell orchestration platforms, through validation and go-live.
- Experience working in a matrix organisation with global headquarters, including cross-time-zone programmes.
- Strong business acumen; able to speak the language of scientists, engineers and quality leaders.
- Excellent stakeholder management and influencing skills, up to executive level.
- Structured problem solving, and comfort with ambiguity in a fast-growing business.
Date Posted
05-11月-2026Closing Date
30-12月-2026AstraZeneca 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 authorization and employment eligibility verification requirements.
