Technical Project Manager - 1099/W2

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