Job Description
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.
