Start: ASAP
Duration: 12 months contract + possible extension
Location: EU
Onsite/Remote: Remote
Language: English
Key Responsibilities:
- Lead global quality, compliance, and validation strategy for digital solutions across manufacturing, material control, warehousing, and laboratories.
- Define and harmonize quality-critical processes ( traceability, lot logic, expiry, quarantine, data integrity) and support management decision-making.
- Oversee end-to-end data flows and ensure regulatory, data integrity, and control requirements are embedded throughout the solution lifecycle.
- Define and govern global SOPs, change control processes, and validation approaches in alignment with Quality Assurance and Regulatory Affairs.
- Lead integral validation strategies and execution for MES, WMS, ERP, and laboratory systems, including planning, documentation, and risk-based validation.
- Coordinate cross-functional and global teams, acting as the key interface between sites, QA, and program leadership.
- Provide expert guidance, training, and support on GxP, CSV, and digital adoption.
- Manage validation resources, timelines, risks, and reporting to ensure on-time delivery within program scope and budget.
Qualifications & Experience:
- Bachelor's or Master's degree in Engineering, IT, Life Sciences, or a related field.
- 10+ years of experience in validation and compliance within manufacturing, supply chain, and laboratory environments.
- Hands-on experience validating enterprise systems such as MES, LIMS, WMS, ERP, and data platforms.
- Strong knowledge of GMP, GDP, CSV, and digital compliance requirements.
- Proven ability to lead global, cross-functional teams in complex, matrix-managed environments.
- Experience delivering IT-enabled programs within international, virtual project teams.
- Excellent communication, stakeholder management, and leadership skills.
- Fluent in English.
Preferred:
- Experience with Körber MES, Lab Vantage LIMS, Infor M3, or similar enterprise platforms.
- Exposure to Scientific Data Cloud, ELN/LES, and laboratory equipment integration.
- Understanding of Industry and digital manufacturing transformation frameworks.
Reference
CR/131044_1769524385
Date
27 Jan 2026