Job Title - Portfolio Leader – Quality & Compliance Systems

Employment Type: Full-Time

Experience: 20+ Years

Location: Remote/Hybrid (Travel as Required)

Job Description: 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.

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, R&D;, 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 general 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

Electronic Quality Management Systems (eQMS)

Quality and Compliance Transformation

CAPA

Deviations and Nonconformance Management

Change Control

Document Management

Training Management

Audit and Inspection Management

Complaints 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

Experience with one or more of the following platforms is preferred:

Veeva Vault Quality

TrackWise Digital

Sparta TrackWise

MasterControl

ETQ Reliance

OpenText Documentum

Kneat Gx

ValGenesis

ComplianceWire

SAP Quality Management

Client 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 Beltn

Key Skills:

Portfolio Management

Program Management

Quality Systems

Compliance Systems

eQMS

Digital Quality

CAPA

Deviations

Change Control

Document Management

Audit Management

Training Management

Complaints Management

Supplier Quality

Life Sciences

Pharmaceutical Industry

Biotechnology

Medical Devices

GxP

FDA 21 CFR Part 11

EU Annex 11

GAMP 5

ISO 13485

ALCOA+

CSV

CSA

Executive Stakeholder Management

Vendor Management

Budget Management

Risk and Governance

Digital Transformation

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