Global Compliance Lead

Role Summary

As the Global Compliance lead you will build up and lead the global program compliance & validation teams ensuring the compliance of the IT solutions being implemented in the domains of manufacturing warehouse & laboratories.

You will coordinate cross-functional teams to ensure the solutions validated state and effective maintenance processes after go-live in line with the project scope to drive operational transformation from paper-based processes to digital workflows.

Key Responsibilities:

• Compliance

• Lead the definition and harmonization of quality critical topics in the domains of manufacturing and material control and prepare the necessary management decisions (such as)
• Lot number logic
• MFG / expiry dates
• Quarantine rules
• Traceability
• Oversee the definitions and documentation of data flows in the e2e process e.g. from incoming material to delivery to customer ensuring that all critical controls including DI are in place
• Define or lead definition of global SOPs covering above topics where relevant
• Oversee definitions and management of change controls (including involvement of regulatory affairs as needed)
• Ensure that requirement specifications and risk assessments includes relevant regulatory and data integrity topics
• Define processes to ensure data integrity controls during the solutions and data life cycles (including retention and archiving rules)
• Align with Quality Assurance on the requirements for validating the solutions and related equipment connectivity during the life cycle
• Support process and system owners to define procedures for maintaining the solutions and master data in compliant state during their life cycle in the most efficient ways
• In cooperation with SMEs and QA define processes for MES MBR verification and lead the execution of the verifications across the sites / production lines
• Support the definition of the operational organization(s) and the transfer to those

Validation Leadership & Coordination

• Lead the definition of the global validation strategies and validation master plans for deployment of MES WMS ERP and laboratory solutions across the sites in alignment with client policies and applicable regulations
• Define local vs. global validation responsibilities during the program and solutions life cycles
• Manage validation planning execution and reporting in cooperation with program and project managers ensuring validation of the end-to-end processes and data flows
• Lead development review and management of validation documentation such as validation plans Installation/Operational/Performance Qualification (IQ/OQ/PQ) protocols traceability matrices test scripts and summary reports.
• Build validation strategies based on risk ensuring re-usability across the sites and leveraging as far as possible supplier deliverables
• Source and lead internal and external validation resources to execute the validation activities

Stakeholder Engagement

• Act as the primary liaison between the site and global validation and QA teams
• Work closely with program and project managers to ensure the validation activities are in line with the overall project planning and budget
• Engage with local & global. QA/QC production supply chain engineering and IT to ensure buy-in and smooth execution
• Guidance and Training: Act as a primary point of contact and provide expert guidance and training to internal teams and stakeholders on GxP compliance and CSV standards.
• Support change management initiatives and promote adoption of digital tools.
• Support the definition of the operational organization(s) and the transfer to those

Performance & Reporting

• Define resource needs and plans for validation activities
• Provide regular updates to the project managers and Global PMO.
• Ensure timely delivery of milestones and manage risks proactively.

Qualifications & Experience:

• Bachelor’s or Master’s degree in Engineering IT Life Sciences or related field.
• 10 years of experience in validation management within manufacturing supply chain and laboratory environments.
• Proven experience with validation of MES LIMS SDC WMS ERP
• Strong understanding of GMP GDP and digital compliance frameworks.
• Experience in leading teams in international and multidisciplinary environments.
• Experience in working on IT projects and programs within multicultural global virtual project teams in a matrix management environment.
• Excellent communication stakeholder management and leadership skills.
• Fluent in English

Preferred Skills:

• Experience with validation of Körber MES Labvantage LIMS Infor M3 or similar ERP systems.
• Experience of Scientific Data Cloud (SDC) ELN/LES and lab equipment integration.
• Knowledge of Industry 4.0 maturity models and digital transformation frameworks.