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 integral 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 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 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