Digital Quality Expert

About the role

Opella, a self-care brand group, is looking for an experienced Digital Quality Expert to embed GxP quality and validation requirements throughout agile digital delivery. You will help project teams keep business-critical systems compliant, validated and audit-ready, working across the Americas and with global colleagues. The role also involves leading initiatives that strengthen the brands' reputation, mentoring emerging talent and embedding sustainability, access and social impact into decisions.

Key responsibilities

• Govern documentation for computerized system validation and assurance, data integrity, cloud and SaaS solutions, and electronic records and signatures.
• Lead or oversee validation planning, risk assessments, testing strategies and approval of validation deliverables.
• Partner with Digital and IT, Engineering, R&D and Supply Chain teams throughout agile delivery.
• Integrate quality requirements into completion criteria and keep systems validated and audit-ready.
• Support deviations, CAPA, change controls, periodic reviews, supplier qualification and inspection readiness.
• Provide clear GxP guidance and training to global stakeholders.

Required profile

• Experience integrating quality and validation activities into agile project delivery, able to simplify complex requirements and collaborate across functions.
• Professional English for collaboration in a global, distributed team.

Required skills

• Computerized system validation, computerized system assurance and ALCOA+ data integrity principles.
• Strong understanding of GAMP 5, Annex 11, 21 CFR Part 11 and risk-based validation.