Portfolio Manager - Quality & Compliance Systems

Portfolio Manager Quality Compliance Systems (Life Sciences) Project Overview Key Responsibilities Portfolio Management

• Lead and govern a portfolio of Quality and Compliance Systems programs across multiple business units, sites, and regions.
• Define portfolio strategy, roadmap, priorities, budgets, resource plans, and investment requirements.
• Monitor portfolio health, delivery milestones, risks, dependencies, financial performance, and value realization.
• Establish governance frameworks, executive dashboards, KPIs, and standardized reporting.
• Ensure alignment of quality technology initiatives with business objectives, regulatory requirements, and enterprise architecture.

Program and Project Leadership

• Manage multiple concurrent quality system implementations, upgrades, migrations, integrations, and modernization initiatives.
• Oversee end-to-end project delivery, including planning, design, configuration, validation, testing, deployment, hypercare, and operational transition.
• Coordinate cross-functional teams, business process owners, vendors, system integrators, and technical teams.
• Identify and resolve cross-program risks, dependencies, resource conflicts, and delivery challenges.
• Ensure projects are delivered within agreed scope, schedule, budget, and quality expectations.

Quality Systems Transformation

• Lead digital transformation initiatives across enterprise quality processes and platforms.
• Manage programs involving:
  • Electronic Quality Management Systems (eQMS)
  • Document Management Systems
  • Learning Management Systems
  • Regulatory Information Management Systems
  • Audit and Inspection Management
  • Corrective and Preventive Action (CAPA)
  • Deviations and Nonconformance Management
  • Change Control
  • Complaints Management
  • Supplier Quality Management
  • Training and Compliance Management
• Drive process standardization, harmonization, automation, and continuous improvement across global quality operations.

Compliance and Validation

• Ensure systems and solutions comply with applicable Life Sciences regulations and quality standards, including:
  • GxP
  • FDA 21 CFR Part 11
  • EU Annex 11
  • GAMP 5
  • ISO 13485
  • ALCOA+ data integrity principles
  • Computer System Validation (CSV)
  • Computer Software Assurance (CSA)
• Ensure appropriate validation, traceability, documentation, and quality oversight throughout the system lifecycle.
• Support regulatory inspections, internal audits, external audits, and remediation activities.
• Ensure systems remain compliant, secure, audit-ready, and fit for intended use.

Business and Stakeholder Management

• Partner with Quality Assurance, Regulatory Affairs, Manufacturing, Laboratory Operations, RD, Supply Chain, IT, and business leadership.
• Facilitate portfolio governance and executive steering committee meetings.
• Provide clear executive-level updates on portfolio status, financials, risks, decisions, and business outcomes.
• Collaborate with global process owners to prioritize initiatives and define transformation roadmaps.
• Drive organizational change management, communications, training, and adoption.

Financial and Vendor Management

• Manage portfolio budgets, forecasts, resource allocation, and financial reporting.
• Oversee software vendors, consulting partners, system integrators, and managed service providers.
• Manage contracts, statements of work, vendor performance, deliverables, and service-level commitments.
• Track portfolio benefits, cost savings, compliance improvements, and return on investment.

Required Qualifications

• Bachelor's degree in Life Sciences, Quality Management, Information Technology, Engineering, Computer Science, or a related discipline.
• 12+ years of experience in IT, Quality Systems, Digital Transformation, or Program Management.
• 5+ years of experience managing enterprise portfolios or large-scale programs involving Quality and Compliance Systems.
• 5+ years of strong experience within the Pharmaceutical, Biotechnology, Medical Devices, Healthcare, or broader Life Sciences industry.
• 5+ years of proven experience leading global, multi-site quality transformation programs.
• 5+ years of demonstrated experience managing executive stakeholders, cross-functional teams, vendors, and implementation partners.
• 5+ years of strong understanding of regulated system delivery and validation lifecycle requirements.

Required Technical and Functional Expertise

• Quality Management Systems
• Quality and Compliance Transformation
• CAPA
• Document Management
• Training Management
• Supplier Quality
• Regulatory Compliance
• Computer System Validation
• Computer Software Assurance
• Portfolio and Program Management
• Vendor and Financial Management
• Risk and Governance Management

Preferred Platform Experience

• Veeva Vault Quality
• TrackWise Digital
• Sparta TrackWise
• MasterControl
• ETQ Reliance
• OpenText Documentum
• Kneat Gx
• ValGenesis
• ComplianceWire
• SAP Quality Management
• ServiceNow GRC
• Oracle Quality Management
• Regulatory Information Management platforms

Preferred Certifications

• PMP or PgMP
• PMI Portfolio Management Professional (PfMP)
• Certified Quality Auditor (CQA)
• Certified Quality Engineer (CQE)
• ASQ or RAC certification
• SAFe Agilist or SAFe Program Consultant
• ITIL Foundation
• Lean Six Sigma Green Belt or Black Belt

Key Skills

• Portfolio Management
• Program Management
• Quality Systems
• Compliance Systems
• eQMS
• Digital Quality
• Deviations
• Audit Management