Digital Quality Expert

1463 Opella Healthcare Spain, S.L.; Bogotá; Vor Ort; COP 189.843.000 - 284.765.000; Vollzeit

Zusammenfassung

Opella is seeking a Digital Quality Expert to embed GxP quality and validation across agile digital delivery, ensuring systems are compliant, validated and audit-ready for global teams.

You'll lead validation planning, risk assessments and testing strategies while partnering with Digital, IT, Engineering, Manufacturing, R&D and Supply Chain to deliver high-quality solutions. Strong English and cross-functional collaboration are essential.

Qualifikationen

• Hands-on knowledge of 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.
• Experience integrating quality and validation activities into agile project delivery.
• Professional English required for collaboration within a global, distributed team.

Aufgaben

• 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, Manufacturing, R&D, and Supply Chain teams throughout agile delivery.
• Integrate quality requirements into completion criteria and maintain systems in a validated, audit-ready state.
• Support deviations, CAPAs, change controls, periodic reviews, supplier qualification and inspection readiness.
• Provide clear GxP guidance and training to global stakeholders.

Kenntnisse

GxP compliance

ALCOA+ data integrity

Computerized system validation

GAMP 5/Annex 11/21 CFR Part 11

Agile delivery experience

Risk-based validation

Professional English

Jobbeschreibung

Digital Quality Expert You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As an experienced Digital Quality Expert, you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human.

About the job:

As a Digital Quality Expert, you will embed GxP quality and validation requirements throughout agile digital delivery, helping project teams keep business-critical systems compliant, validated and audit-ready.

Working across the Americas and with global colleagues, you will turn complex quality requirements into clear, practical guidance that enables effective and compliant delivery.

Lead initiatives that advance our brands and strengthen our reputation worldwide.

Mentor and uplift emerging talent while pushing your own growth and influence.

Put purpose into practice ‑ embedding sustainability, access and social impact into every decision.

Model the challenger mindset: question complexity, act with integrity and make things radically simple.

Help shape a culture that’s ambitious, collaborative and serious about recognition and belonging.

Main responsibilities:

Govern documentation for computerized system validation and assurance, data integrity, cloud and software-as-a-service solutions, and electronic records and signatures.

Lead or oversee validation planning, risk assessments, testing strategies and approval of validation deliverables.

Partner proactively with Digital and Information Technology, Engineering, Manufacturing, Research and Development, and Supply Chain teams throughout agile delivery.

Integrate quality requirements into completion criteria and maintain systems in a validated, audit-ready state.

Support deviations, corrective and preventive actions, change controls, periodic reviews, supplier qualification and inspection readiness.

Provide clear GxP guidance and training to global stakeholders.

About you:

Hands-on knowledge of computerized system validation, computerized system assurance and ALCOA+ data integrity principles.

Strong understanding of GAMP 5, Annex 11, 21CFRPart11 and risk-based validation.

Experience integrating quality and validation activities into agile project delivery, with the ability to simplify complex requirements and collaborate proactively across functions.

Professional English required for collaboration within a global, distributed team.

This is more than the next step in your career, it’s a chance to lead change and help reinvent self-care for the world.

If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you.

We are challengers. We are Opella.

Opella values diversity in all its forms and is committed to fostering a workplace where everyone can belong and excel. We welcome and encourage applications from people of all backgrounds.

About Us:

Opella is the self‑care challenger with the purest and third‑largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self‑care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000‑strong global team, our 13 best‑in‑class manufacturing sites and our 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.

As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.

Opella is the self‑care challenger with the purest and third‑largest portfolio in the Over‑The‑Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self‑care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000‑strong global team, our 13 best‑in‑class manufacturing sites and our 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.