Technical Project Manager - 1099/W2 at Gmppros

Job description

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

Requirements

Must-haves

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

Nice-to-haves

Prior experience in a prime/subcontract delivery model or multi-vendor program environment preferred
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

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