Technical Project Manager – MSPP Platform Qualification (GxPSOX)

Job Summary
We are seeking a high-caliber Technical Project Manager and MSPP Platform Expert to lead the qualification and validation of our Multi-Service Provisioning Platform. This role is critical for ensuring that our technical infrastructure meets global GxP (Good Practice) standards for patient safety and SOX (Sarbanes-Oxley) requirements for financial data integrity. You will act as the primary technical liaison between Engineering Quality Assurance (QA) Regulatory Affairs and external stakeholders.
Key Responsibilities
Platform Qualification & Validation: Lead end-to-end qualification (IQ/OQ/PQ) for the MSPP platform ensuring all technical components comply with 21 CFR Part 11 and Annex 11.
Regulatory Compliance: Define and execute a robust SOX control framework for the platform managing evidence gathering and audit trails.
Stakeholder Collaboration: Serve as the bridge between technical delivery teams and non-technical business leaders to align platform capabilities with regulatory expectations.
Technical Expert Leadership: Provide deep technical guidance on MSPP architecture including optical transport and service interfaces to optimize system performance within a validated state.
Risk & Change Management: Conduct GxP-focused risk assessments and manage technical change controls to maintain inspection-ready status.
Experience:
Minimum 5-8 years of Project Management experience in a highly regulated technical environment (Pharma MedTech or Finance).
Proven track record in Computer System Validation (CSV) and GxP/SOX platform qualification.
Technical Expertise: Deep knowledge of Multi-Service Provisioning Platforms (MSPP) and their integration into enterprise IT landscapes.
Regulatory Knowledge: Familiarity with FDA/EMA guidelines data integrity principles (ALCOA) and financial control frameworks.
Certifications: PMP PRINCE2 or CSM preferred; GxP or Quality Management certifications are a significant plus.
Core Competencies
Adaptive Communication: Ability to translate complex technical MSPP specifications into regulatory impact statements for stakeholders.
Strategic Leadership: Capability to lead cross-functional pods including Backend Developers QA Leads and Compliance Officers.
Analytical Problem-Solving: Skilled in gap analysis CAPA (Corrective and Preventive Actions) and root cause investigation.