Program Manager – Quality & Compliance Systems - 2847
On-siteLa Ciudad, Estado de Durango, Mexico
Job Summary
Lead global Quality & Compliance Systems programs by defining objectives, roadmaps, and governance aligned with corporate strategy and regulatory requirements. Drive implementation, modernization, and integration of eQMS, document management, CAPA, deviations, change control, and validation platforms while ensuring standardization and automation across ERP, MES, LIMS, and CRM ecosystems. Develop comprehensive plans, budgets, and resource allocations to coordinate multidisciplinary teams through design, configuration, validation, deployment, and Hypercare phases. Guarantee adherence to GxP, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ISO 13485, ALCOA+, and CSA standards by maintaining documentation, traceability, and audit readiness. Manage stakeholder relationships with Quality, Regulatory Affairs, Manufacturing, Laboratory Operations, R&D, IT, and executive leadership to facilitate governance, track indicators, and mitigate technical and operational risks. Administer budgets, contracts, and SOWs while supervising vendors to ensure deliverable compliance. Coordinate change management, communication, and user training to guarantee successful operational transitions. Work remotely from Mexico with a Monday–Friday schedule from 09:00–18:00. Join a global team driving digital quality transformation in the Life Sciences sector.
Required Qualifications
- 10-15+ años de experiencia en Program Management, Sistemas de Calidad, Validación, Transformación Digital o TI
- 5+ años liderando programas de Calidad y Cumplimiento
- Experiencia en la industria Farmacéutica, Biotecnología, Dispositivos Médicos o Life Sciences
- Experiencia liderando iniciativas globales o multisitio, coordinando equipos de Calidad, Regulación, TI, Validación y proveedores
- Conocimiento sólido del ciclo de vida de sistemas regulados
- Conocimientos técnicos: QMS/eQMS y Transformación Digital de Calidad, CAPA, desviaciones y no conformidades, control de cambios, gestión documental y de capacitación, auditorías e inspecciones, gestión de quejas y de calidad de proveedores, cumplimiento regulatorio, validación (CSV/CSA), gestión de programas y proyectos, gestión de proveedores, presupuesto, stakeholders ejecutivos, riesgos y cambio organizacional
- Inglés avanzado (Nivel C1 en adelante)
- Trabajo remoto desde México
- Horario laboral de lunes a viernes, 09:00 – 18:00
Desired Qualifications
- Veeva Vault Quality
- TrackWise (Digital/Sparta)
- MasterControl
- ETQ Reliance
- OpenText Documentum
- Kneat Gx
- ValGenesis
- ComplianceWire
- SAP QM
- ServiceNow GRC
- Oracle Quality Management
- plataformas RIM
- Certificaciones deseables: PMP, PgMP, SAFe Agilist/SPC, ITIL Foundation, CQA, CQE, ASQ o RAC, Lean Six Sigma (Green/Black Belt) y certificaciones Agile o Scrum
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