技术项目经理 - 1099/W2
Technical Project Manager - 1099/W2
负责交付的TPM。这不是一个协调或报告的角色——TPM负责详细的MS Project计划、关键路径、风险识别与升级、跨工作流依赖管理，并对牛津分包商下的GMP Pros表现负全责。TPM还负责验证文档层：协议规划、Kneat事件协调，以及两个工作流中的Veeva VQD文档监督。该职位需要能够在三方治理结构（GMP Pros / 牛津 / GSK）中运作，处理竞争性优先级和重大时间压力。
所需资格
- 在FDA监管的制药或生物制药制造环境中拥有5年以上项目管理经验
- 有直接管理MES或eBR实施项目的经验（Siemens OpCenter、Rockwell PharmaSuite、Emerson DeltaV Batch或同等系统），从设计到PPQ阶段
- 熟练使用MS Project进行计划开发、关键路径定义和基线管理——不仅仅是甘特图创建，而是在压力下进行主动计划管理
- 了解21 CFR Part 11、EU Annex 11和CSV/CQV生命周期：IQ/OQ/PQ结构、验证协议编写和受监管系统的文档要求
- 有使用Kneat或等效电子验证管理系统进行协议编写和事件管理的经验
- 有使用Veeva Vault QualityDocs（VQD）或等效QMS/DMS管理验证生命周期文档的经验
- 有管理风险登记表、主动升级并保护计划而不制造噪音的能力——GSK会密切关注这一点
- 有在主承包/分包交付模式或多供应商项目环境中的经验者优先
优选资格
- 拥有PMP认证或其他项目管理资质
- 有直接使用Siemens OpCenter Execution Pharma（前身为SIMATIC IT）的经验
- 有支持PPQ执行和上线后超期维护活动的经验
- 熟悉GSK、辉瑞、默克、礼来或其他大型制药企业的MES环境
- 熟悉制药制造环境中的SAP-MES和OSI-PI集成
关键工具与平台
MS Project（必需） | Kneat（优先） | Veeva VQD（优先） | Siemens OpCenter（需熟悉） | SAP | OSI-PI / PI System | Microsoft Teams / SharePoint
查看英文原文
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
Originally posted on Himalayas