Technical Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Take full ownership and accountability for the performance of GMP Pros under the Oxford subcontract.

• Create and actively oversee a comprehensive MS Project schedule, including managing the critical path and baseline.

• Proactively identify and escalate potential risks.

• Manage dependencies across various workstreams.

• Oversee the validation documentation for both workstreams.

• Plan and develop validation protocols.

• Coordinate incidents related to Kneat.

• Supervise Veeva VQD documentation processes.

• Work within a three-party governance framework that includes GMP Pros, Oxford, and GSK.

• Handle competing priorities and operate under significant scheduling pressures.

⛳️ Requirements

• Over 5 years of project management experience in FDA-regulated pharmaceutical or biopharmaceutical manufacturing settings.

• Direct experience in managing MES or eBR implementation projects from design to PPQ, including Siemens OpCenter, Rockwell PharmaSuite, Emerson DeltaV Batch, or similar systems.

• Proficient in MS Project for developing schedules, defining critical paths, and managing baselines.

• Solid understanding of 21 CFR Part 11, EU Annex 11, and the CSV/CQV lifecycle.

• Experience with IQ/OQ/PQ structure, authorship of validation protocols, and documentation requirements in regulated environments.

• Familiarity with Kneat or equivalent electronic validation management systems for protocol authorship and incident handling.

• Experience with Veeva Vault QualityDocs (VQD) or similar QMS/DMS for validation documentation throughout the lifecycle.

• Ability to manage risk registries, escalate issues proactively, and safeguard schedules.

• PMP certification or a comparable project management credential is preferred.

• Direct experience with Siemens OpCenter Execution Pharma is preferred.

• Experience in supporting PPQ execution and providing post-go-live hypercare is preferred.

• Familiarity with large pharmaceutical MES environments, such as GSK, Pfizer, Merck, or Lilly, is preferred.

• Knowledge of SAP-MES and OSI-PI integrations within a pharmaceutical manufacturing context is preferred.

• Familiarity with Microsoft Teams and SharePoint.

• Previous experience in a prime/subcontract delivery model or a multi-vendor program environment is preferred.

🏝️ Benefits

• Options for 1099/W2 engagement.

• Opportunity for remote work.