Job Description
As a seasoned Operational Excellence Manager, you will lead the implementation of manufacturing strategies aligned with business and regulatory requirements.
You will define and implement best practices for process manufacturing, including work order execution, multi-level BOMs, sub-assemblies, and recipes.
Key Responsibilities
* Collaborate with production planners, quality, and IT to configure manufacturing parameters, routings, and integration points.
* Ensure accurate and compliant setup of manufacturing master data (materials, BOMs, routings, production versions).
* Create and maintain process documentation and participate in ERP testing phases to validate manufacturing functionality.
GxP Compliance & Validation
* Ensure manufacturing processes comply with GxP regulations, including 21 CFR Part 11 and EU GMP Annex 11.
* Support Computer System Validation activities and implement controls for electronic signatures, audit trails, and batch traceability.
Stakeholder Engagement
* Act as the primary liaison for all production-related ERP matters across internal departments.
* Facilitate workshops and training sessions to promote process ownership and operational excellence.
Operational Excellence
* Define and monitor manufacturing KPIs (e.g., throughput, yield, downtime) post-ERP implementation.
* Drive improvements in production scheduling, resource utilization, and shop floor visibility.
The ideal candidate will have senior leadership experience in manufacturing or operations within regulated pharma or CDMO environments.
Demonstrated success in ERP implementation, particularly SAP. Relevant academic qualifications in engineering, manufacturing, or life sciences. SAP certification or supply chain/manufacturing credentials desirable.