About the job Senior SAP ERP Validation Manager
**About the Opportunity**
Our client is a globally recognised leader in the biotechnology and pharmaceutical industry, at the forefront of innovative medicine. Their Shanghai site plays a critical role in global manufacturing and quality operations.
This is a high-visibility, high-impact senior individual contributor role, serving as the primary Subject Matter Expert (SME) for SAP ERP Computerised System Validation (CSV). You will ensure the ERP application landscape remains in a validated state under global regulatory frameworks, acting as the critical bridge between IT, Quality Assurance (QA), and business stakeholders.
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**The Role**
As Senior SAP ERP Validation Manager, you will serve as the CSV project lead, conducting validation of the SAP ERP system in accordance with the company's Quality Management System (QMS) and applicable regulatory requirements including:
- FDA 21 CFR Part 11
- EU GMP Annex 11
- China GxP regulations (NMPA)
- Sarbanes-Oxley (SOX) Section 404
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**Key Responsibilities**
- Lead CSV project delivery — develop and execute validation strategies for computerised systems in scope, ensuring ongoing GxP compliance
- Draft, review, and approve CSV documentation (VMP, URS, FS, DS, IQ, OQ, PQ, Traceability Matrix) in line with SOPs, guidelines, and applicable regulations
- Work closely with IT, QA, and business stakeholders to manage change control, deviation handling, and CAPA processes
- Serve as SAP ERP compliance SME during internal audits, vendor audits, and health authority inspections (including FDA and NMPA)
- Contribute to the development and continuous improvement of the computerised systems compliance framework
- Support periodic reviews and lifecycle management of validated systems
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**Essential Requirements**
- 5+ years of hands-on Computerised System Validation (CSV) experience in a GxP-regulated industry (pharmaceutical or biotech preferred)
- Deep working knowledge of SAP ERP in a life sciences validation context
- Solid understanding of FDA 21 CFR Part 11, EU GMP Annex 11, and China GxP/NMPA regulations; SOX 404 familiarity desirable
- Proven experience leading audits and regulatory inspections as a compliance SME
- Strong documentation skills — able to draft and review validation documents to inspection standard
- Excellent stakeholder management and cross-functional communication skills
- Fluent English and Mandarin (written and spoken) — essential
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**Desirable Requirements**
- Experience with SAP S/4HANA validation or migration projects
- Familiarity with GAMP 5 (2nd edition) and risk-based validation approaches
- Multi-site or global experience within an MNC pharma/biotech environment
- Degree in a relevant scientific, engineering, or information systems discipline
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**Compensation & Benefits**
Our client offers a competitive total compensation package above senior MNC pharma benchmarks in Shanghai.
- Annual performance bonus based on individual and company performance
- 13th month salary (standard for MNC employers in Shanghai)
- Comprehensive commercial health insurance: inpatient and outpatient coverage, including dependants
- Housing or transportation allowance (confirmed at offer stage)
- Statutory China social insurance and housing fund
- Training and professional development budget including GxP and regulatory CPD
- Employee equity/stock plan (subject to eligibility and grade)
Note: Final package is negotiable and will be discussed in detail once a candidate is shortlisted. All figures are gross annual CNY pre-tax.
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**How to Apply**
This search is managed exclusively by Myn. For a confidential discussion or to express interest, please contact us directly.
Please note: All applications must be submitted in English.
Contact: Mo Mohamed
Email: mo.mohamed@m2talents.com
All applications and enquiries are handled in strict confidence.