Job Title - Senior Expert Global Sector Audit
Location - Preferably Bonn, Flexible for other locations
Job Purpose
At DHL Global Forwarding, the Senior Expert Global Sector Audit operates at the critical intersection of IT, Quality Assurance, and Regulatory Compliance.
This role ensures that the global Sector Audit Programs and the global Computer System Validation (CSV) Program are effectively implemented and continuously enhanced to meet both customer expectations and the requirements of regulatory / industry bodies.
The role is responsible for proactively identifying, shaping, and prioritizing activities across the programs through a structured, risk-based approach, with the objective to verify the organizations compliance with product and sector regulatory requirements and to maintain Programs which support the DGF to operate in compliance with Life Sciences & Healthcare (LSH) and other regulated sector requirements.
Differentiator
* A highly experienced problem-solver who combines structured thinking with strong quality mindset and understanding of the LSH sector requirements.
* Experience of working in a complex, global matrix environment and across Divisional Business Units and CSI.
* Proven track record in Computer System Validation following GAMP5 guidelines.
* Good knowledge of Freight Forwarding operational processes as well as common computers system development frameworks.
* Extensive knowledge of GDP and GSP regulations and guidelines applicable for the Freight Forwarding Industry, GAMP5 guidelines and Quality Management Systems.
* Experience with conducting audits in regulated sector environments.
* Geographical Experience: Global/Regional/Country with an ability to understand cultural differences and adjust working style/approach accordingly.
* Self-starting, independent and yet team-oriented, flexible with hours.
* Above-average commitment, ability to work under pressure and flexibility
* Willingness to travel & work internationally < 30%.
* Experience with applying and assessing Artificial Intelligence (AI) in regulated environments (GxP/CSV).
Key Tasks
* Implement and enhance the DGF global Computer System Validation Program as a Quality Assurance Management System covering global computerized systems provided by and to the DGF organization.
o Engage across DHL Divisions/CSI and with Corporate Specialists to ensure DHL provided applications are compliant with DGF global CSV requirements.
o Provide DGF CSV stakeholders with training concerning CSV knowledge, skills, experience and expertise
o Monitor and follow up with application owners on the CSV documentation status
o Support the implementation of the global CSV Program by e.g.:
+ Identification of CSV relevant computerized systems that are provided by DHL or DGF Global to the organization.
+ Review of CSV assessments, processes documentation and qualification / validation documentation of relevant computerized systems in accordance with applicable procedures.
o Verify the compliant implementation of the CSV program of in-scope computerized systems.
* Implement and enhance the global Sector Audit Programs covering in-scope regulated sectors as requested by the global Product Organizations.
o Monitor and perform regular follow-up with stations and lead auditors on the audit progress.
o Perform Sector Audits globally and support the review of audit reports conducted by other lead auditors.
o Provide training to DGF Sector Auditors concerning sector requirements, auditor skills, experience and expertise
* Participate in customer audits together with global IT and global Product to present the global Sector Audit and the global CSV Programs.
* Develop innovative use of technology in the audit and CSV function
* Support regulatory compliance projects
* Liaise with industry bodies and professional associations like e.g. IATA and ISPE.
* Provide regular status updates to the relevant management stakeholders.
Stakeholders
* Internally: Global IT, Global Product Heads, CSI, Global & Regional IMS owners, Station, Country and Regional Management, Corporate and Cross Divisional IT.
* External: Customers, Industry Bodies
Management Responsibility
Global Head of Sector Audit
Skills
Problem structuring, stakeholder management, risk management, CAPA management, prioritization, facilitation, communication, data-driven decision-making, quality management, validation of computer systems, GAMP 5, audit skills, GxP, First Choice, IATA CEIV Pharma, understanding of software development methodologies and IT system landscapes.
Qualifications & Key Requirements
Educational level
Bachelor’s degree in computer science, pharmaceutical sciences, medicine, natural science, quality management or a related field.
Experience level
5–8 years’ experience in quality management, computer system validation or adjacent roles requiring the structured implementation and verification of processes in the Life Science industry or any other strongly regulated industry.