
Transformational Project Manager – Regulatory Compliance
2 days ago
We seek a Senior PMO Consultant with PLM expertise, especially in PTC Windchill v13.
This role leads a global upgrade project for a healthcare and life sciences industry leader providing end-to-end design, engineering, manufacturing, and supply chain services.
The company drives improvements across healthcare systems and patient outcomes with expertise in regulated environments and quality, compliance, and innovation focus.
- Lead planning and execution of a Windchill v13 upgrade ensuring business continuity and platform modernization.
- Develop detailed project plans and implementation schedules incorporating PMBOK standards and stakeholder requirements.
- Manage change control processes and oversee overall project execution and risk mitigation.
- Serve as escalation point for project risks and issues applying structured problem-solving to resolve challenges.
- Oversee validation protocols and compliance deliverables in accordance with FDA, GxP, and 21 CFR Part 11.
- Collaborate with Quality Systems Managers, CSV leads, and PLM/PDM owners to validate BOM structures ECN workflows and product data governance.
- Ensure seamless integration between Windchill and SAP NSP/ECC systems.
- Manage vendor relationships enforcing SoW/T&M terms negotiating boundaries and resolving conflicts between system integrators.
- Lead steering committees executive reporting RAID log ownership and cross-vendor governance.
Bachelor's degree + 8 years or Master's degree + 6 years of related experience are required.
- Extensive experience in the life sciences industry with strong exposure to validation.
- Deep knowledge of PLM platforms preferably PTC Windchill PDM processes and Quality Management Systems.
- Skills & Competencies:
- Vendor Management: proven experience with third-party vendors/SIs.
- Migration & Upgrade Experience: SaaS/cloud transitions system upgrades data migration strategies.
- Validation & Regulated Industry Knowledge: CSV/CSA SDLC and compliance frameworks.
- Communication & Governance: steering committees executive reporting RAID management.
PREFERRED QUALIFICATIONS
- PMP (Project Management Professional)
- CSM / Advanced ScrumMaster
- Expertise in Agile Waterfall Hybrid and DevOps methodologies.
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