The TPM owns the delivery. This is not a coordination or reporting role — the TPM is responsible for the detailed MS Project schedule, critical path, risk identification and escalation, cross-workstream dependency management, and full accountability for GMP Pros' performance under the Oxford subcontract. The TPM also owns the validation documentation layer: protocol planning, Kneat incident coordination, and Veeva VQD documentation oversight across both workstreams. This person must be comfortable operating in a three-party governance structure (GMP Pros / Oxford / GSK) with competing priorities and significant schedule pressure.
Required Qualifications
- 5+ years of project management experience in FDA-regulated pharmaceutical or biopharmaceutical manufacturing environments
- Direct experience managing MES or eBR implementation projects (Siemens OpCenter, Rockwell PharmaSuite, Emerson DeltaV Batch, or equivalent) from design through PPQ
- Proficiency with MS Project for schedule development, critical path definition, and baseline management — not just Gantt creation, but active schedule management under pressure
- Working knowledge of 21 CFR Part 11, EU Annex 11, and the CSV/CQV lifecycle: IQ/OQ/PQ structure, validation protocol authorship, and documentation requirements in regulated systems
- Experience with Kneat or an equivalent electronic validation management system for protocol authorship and incident management
- Experience with Veeva Vault QualityDocs (VQD) or an equivalent QMS/DMS for managing validation lifecycle documentation
- Demonstrated ability to manage risk registries, escalate proactively, and protect schedule without creating noise — GSK will be watching this closely
- Prior experience in a prime/subcontract delivery model or multi-vendor program environment preferred
Preferred Qualifications
- PMP certification or equivalent project management credential
- Direct experience with Siemens OpCenter Execution Pharma (formerly SIMATIC IT)
- Experience supporting PPQ execution and post-go-live hypercare activities
- Familiarity with GSK, Pfizer, Merck, Lilly, or other large pharma MES environments
- Familiarity with SAP-MES and OSI-PI integrations in a pharma manufacturing context
Key Tools & Platforms
MS Project (required) | Kneat (preferred) | Veeva VQD (preferred) | Siemens OpCenter (familiarity required) | SAP | OSI-PI / PI System | Microsoft Teams / SharePoint
