Job Title - Portfolio Leader – Quality & Compliance Systems Employment Type: Full-Time

Location: Remote/Hybrid (Travel as Required) Portfolio Leader – Quality & Compliance Systems (Life Sciences)

Project Overview

We are seeking an experienced Portfolio Leader to lead a portfolio of strategic Quality and Compliance Systems initiatives within a global Life Sciences organization. This role will be responsible for managing enterprise-wide quality transformation programs, regulatory compliance initiatives, and digital quality platforms that support Pharmaceutical, Biotechnology, Medical Devices, Manufacturing, Laboratory, and R&D; operations.

The ideal candidate will have strong experience managing complex quality and compliance technology portfolios in regulated environments. This role requires close collaboration with Quality Assurance, Regulatory Affairs, Manufacturing, Laboratory Operations, IT, Validation, Audit, and external implementation partners to deliver compliant, scalable, and business-aligned solutions. 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.

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.

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.

Electronic Quality Management Systems (eQMS)

Change Control

Supplier Quality Management

Training and Compliance Management

Drive process standardization, harmonization, automation, and continuous improvement across global quality operations.

Ensure systems and solutions comply with applicable Life Sciences regulations and quality standards, including:

ALCOA+ data integrity principles

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.

Partner with Quality Assurance, Regulatory Affairs, Manufacturing, Laboratory Operations, R&D;, Supply Chain, IT, and business leadership.

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.

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.

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 integral, multi-site quality transformation programs.

Quality Management Systems

Electronic Quality Management Systems (eQMS)

Quality and Compliance Transformation

Change Control

Training Management

Supplier Quality

Computer Software Assurance

Veeva Vault Quality

TrackWise Digital

SAP Quality Management

Oracle Quality Management

PMP or PgMP

Certified Quality Auditor (CQA)

Certified Quality Engineer (CQE)

ITIL Foundation

Quality Systems

Digital Quality

Change Control

Training Management

Supplier Quality

Medical Devices

Budget Management

Digital Transformation

📌 Senior Portfolio Manager (Ciudad de México)
🏢 Pyramid Consulting
📍 Ciudad de México