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Manager, Global Supply Chain Compliance
1 month ago
The Global Supply Chain Compliance Manager ensures GxP compliance in GSC by providing QMS operational support and partnering in business activities, while identifying and supporting process improvements.
The role involves managing Global Supply Chain compliance, monitoring process performance, performing trend analysis and supporting audit readiness, and developing training strategies. Additionally, the manager handles document management on EDMS, and serves as a functional expert and advisor.
- Collaborate with GSC functions to maintain GxP compliance and to support business activities in compliance with procedural requirements.
- Serve as advisor and functional expert as an accepted body of knowledge and experience in area of expertise.
- Collaborate with GSC Global process owners in designing, managing, and improving capabilities.
- Contribute to the development and implementation of training strategies to achieve consistency and compliance. Deliver training as required.
- Support the development of procedures for optimized efficiency and effectiveness, meeting requirements and enabling strategic goals.
- Monitor compliance and report performance metrics and perform trend analysis for processes as required
- Manage documents and records on EDMS and support other teams as appropriate.
- Work cross functionally to support compliance activities
- Own / support eQMS records such as deviations, change controls, CAPAs and risk assessments on behalf of GSC functions. Perform role of lead investigator as required
- Support audit readiness to ensure GSC functions are prepared and supported accordingly
- Execute self inspections.
- Participation in process / system enhancements.
- Write, revise and review documentation where necessary
- Communicate compliance risk/issues, project updates and escalate as appropriate.
GSC Compliance Manager may be delegated responsibility for eQMS activities such as Infinity change owner, deviation owner etc to support GSC roles for example Market Supply Orchestrator or Finished Good planner.
Essential:
- Excellent interpersonal skills
- Excellent communication skills
- Technical writing capability
- Good time management and organisational skills
- Ability to multi-task numerous projects
- Ability to work with initiative
- Ability to achieve targets and milestones
- Flexible and motivated
- Data analysis
- Supply Chain Acumen
- Confident public speaker
- Ability to solve routine problems
- Bachelors degree in Supply Chain, Engineering, or related Scientific/ Technical discipline
- More than 5 years in a compliance and/or quality assurance.
- Working knowledge GDP/ GMP and of e-Quality Management systems (eQMS) e.g. Veeva Vault
- Experience in Supply Chain
- Experience working in a highly regulated environment
- Cross functional collaboration experience developing systems and standard ways of working, digitized metrics and reporting
