Program Manager – Quality & Compliance Systems - 2847

Role Summary

Program Manager – Quality & Compliance Systems (Life Sciences)

We are looking for a Program Manager to lead strategic Quality and Compliance Systems initiatives within a global organization in the Life Sciences sector. We are looking for a professional with experience leading global quality technology programs in highly regulated environments, collaborating with Quality Assurance, Regulatory Affairs, Manufacturing, Laboratory Operations, R&D, IT, Validation teams and implementation partners.

Responsibilities

Program Leadership: Lead global Quality and Compliance Systems programs, defining objectives, scope, roadmap and governance, aligned with corporate strategy and regulatory requirements.

Systems Implementation: Lead the implementation, modernization and integration of platforms such as eQMS, document management, CAPA, deviations, change control, audits, complaint management, supplier quality and validation, promoting standardization, automation and integration with systems such as ERP, MES, LIMS and CRM.

• Planning and Execution: Develop program plans, schedules, budgets and resources; coordinate multidisciplinary teams; and ensure the execution of design, configuration, validation, deployment and Hypercare.
• Regulatory Compliance: Ensure compliance with standards such as GxP, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ISO 13485, ALCOA+, CSV and CSA, ensuring documentation, traceability and audit preparation.
• Stakeholder Management: Collaborate with Quality, Regulatory Affairs, Manufacturing, Laboratories, IT and executive leadership teams, facilitating governance and monitoring of indicators, risks and results.
• Risk Management: Identify, evaluate and mitigate regulatory, technical and operational risks, coordinating remediation plans when necessary.
• Financial and Supplier Management: Manage budgets, contracts and SOWs, supervising suppliers and ensuring compliance with program deliverables and objectives.
• Change Management: Lead change management, communication, training and user adoption to ensure a successful transition into operation.

Requirements

• 10-15+ years of experience in Program Management, Quality Systems, Validation, Digital Transformation or IT.
• 5+ years leading Quality and Compliance programs.
• Experience in the Pharmaceutical, Biotechnology, Medical Devices or Life Sciences industry.
• Experience leading global or multi-site initiatives, coordinating Quality, Regulatory, IT, Validation and supplier teams.

Solid knowledge of the life cycle of regulated systems

Technical knowledge: QMS/eQMS and Digital Quality Transformation, CAPA, deviations and non-conformities, change control, document and training management, audits and inspections, supplier complaints and quality management, regulatory compliance, validation (CSV/CSA), program and project management, supplier management, budget, executive stakeholders, risks and organizational change.

Advanced English (Level C1 onwards).

Key Skills

Program Management, eQMS, Digital Quality Transformation, CAPA, Change Control, Document Management, Audit Management, Supplier Quality, Regulatory Compliance, Life Sciences, Pharmaceutical Industry, Biotechnology, Medical Devices, GxP, FDA 21 CFR Part 11, GAMP 5, ISO 13485, CSV/CSA, Risk Management, Supplier Management, Change Management.

Desirable

• Veeva Vault Quality, TrackWise (Digital/Sparta), MasterControl, ETQ Reliance, OpenText Documentum, Kneat Gx, ValGenesis, ComplianceWire, SAP QM, ServiceNow GRC, Oracle Quality Management or RIM platforms.
• Desirable certifications: PMP, PgMP, SAFe Agilist/SPC, ITIL Foundation, CQA, CQE, ASQ or RAC, Lean Six Sigma (Green/Black Belt) and Agile or Scrum certifications.

Benefits

• Attractive salary + Benefits above the law.
• Performance bonus, food vouchers and savings fund.
• Bonus, vacation bonus and paid vacations.
• Major medical insurance (SGMM), family insurance and life insurance.
• Join a global team and help lead the transformation of quality and compliance systems. Apply today!
• Remote work from Mexico.
• Working hours Monday to Friday, 09:00 – 18:00.

About the Company

Join a leading IT services company and be part of a dynamic team delivering high-impact solutions for global clients. We are currently looking for skilled professionals to join our Mainframe development projects with a focus on innovation and excellence.