Job Title - Portfolio Leader – Quality & Compliance SystemsEmployment Type: Full-TimeExperience: 20+ YearsLocation: Remote/Hybrid (Travel as Required)Job Description: Portfolio Leader – Quality & Compliance Systems (Life Sciences)Project OverviewWe 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 ManagementLead 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 LeadershipManage 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 TransformationLead digital transformation initiatives across enterprise quality processes and platforms.Manage programs involving:Electronic Quality Management Systems (eQMS)Document Management SystemsLearning Management SystemsRegulatory Information Management SystemsAudit and Inspection ManagementCorrective and Preventive Action (CAPA)Deviations and Nonconformance ManagementChange ControlComplaints ManagementSupplier Quality ManagementTraining and Compliance ManagementDrive process standardization, harmonization, automation, and continuous improvement across global quality operations.Compliance and ValidationEnsure systems and solutions comply with applicable Life Sciences regulations and quality standards, including:GxPFDA 21 CFR Part 11EU Annex 11GAMP 5ISO *****ALCOA+ data integrity principlesComputer 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 ManagementPartner 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 global process owners to prioritize initiatives and define transformation roadmaps.Drive organizational change management, communications, training, and adoption.Financial and Vendor ManagementManage 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 integral, 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 ExpertiseQuality Management SystemsElectronic Quality Management Systems (eQMS)Quality and Compliance TransformationCAPADeviations and Nonconformance ManagementChange ControlDocument ManagementTraining ManagementAudit and Inspection ManagementComplaints ManagementSupplier QualityRegulatory ComplianceComputer System ValidationComputer Software AssurancePortfolio and Program ManagementVendor and Financial ManagementRisk and Governance ManagementPreferred Platform ExperienceExperience with one or more of the following platforms is preferred:Veeva Vault QualityTrackWise DigitalSparta TrackWiseMasterControlETQ RelianceOpenText DocumentumKneat GxValGenesisComplianceWireSAP Quality ManagementClient GRCOracle Quality ManagementRegulatory Information Management platformsPreferred CertificationsPMP or PgMPPMI Portfolio Management Professional (PfMP)Certified Quality Auditor (CQA)Certified Quality Engineer (CQE)ASQ or RAC certificationSAFe Agilist or SAFe Program ConsultantITIL FoundationLean Six Sigma Green Belt or Black BeltnKey Skills:Portfolio ManagementProgram ManagementQuality SystemsCompliance SystemseQMSDigital QualityCAPADeviationsChange ControlDocument ManagementAudit ManagementTraining ManagementComplaints ManagementSupplier QualityLife SciencesPharmaceutical IndustryBiotechnologyMedical DevicesGxPFDA 21 CFR Part 11EU Annex 11GAMP 5ISO *****ALCOA+CSVCSAExecutive Stakeholder ManagementVendor ManagementBudget ManagementRisk and GovernanceDigital Transformation

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