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 (eg 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 life cycle.
• Define and govern global SOPs, change control processes, and validation approaches in alignment with Quality Assurance and Regulatory Affairs.
• Lead global 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, LabVantage LIMS, Infor M3, or similar enterprise platforms.
• Exposure to Scientific Data Cloud, ELN/LES, and laboratory equipment integration.
• Understanding of Industry 4.0 and digital manufacturing transformation frameworks.