Job title : Digital Quality Expert
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 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 .
About the Job:
We are looking for an experienced GxP Digital Quality professional (10-12 years) to join our Hyderabad, India team as Project Support — Digital Quality . As the global owner for Digital Quality standards , you will bring both strategic vision and operational excellence to our quality systems, ensuring compliance with global regulatory requirements and Opella's internal procedures.
You will act as a Challenger — driving continuous improvement, simplifying complex processes, and partnering across functions to ensure every digital solution — from legacy systems to emerging platforms — is compliant, validated, and audit-ready.
This role is for someone who owns the outcome, not just the task , and who thrives in a fast-paced, cross-functional environment where quality is everyone's responsibility.
Main responsibility:
1. Global Quality Policy & Documentation Governance
Own it end-to-end: Act as the global owner for GxP-relevant Digital Quality Policies, Standards, SOPs, and Work Instructions — and make them work in practice, not just on paper.
Manage the lifecycle: Ensure controlled document management across critical areas including CSV/CSA, Data Integrity (ALCOA+), Cloud/SaaS governance, and Electronic Records/Signatures.
Keep it current: Maintain and evolve policies for Periodic Reviews and system lifecycle management, ensuring alignment with corporate and regulatory requirements.
2. Validation Expertise & Risk Management
Lead planning and execution of validation and CSV activities for projects and operations, ensuring fit-for-purpose documentation — executed at pace, without waiting for perfection .
Provide quality oversight and technical leadership for Computer System Validation (CSV), including management and approval of quality notifications.
Collaborate with project teams, engineering, IT, and operations to support system design, testing, release, and handover.
Apply risk-based approaches to validation decisions, documenting rationale clearly for all stakeholders.
Act as the tactical expert for computerized system validation using GAMP 5 and CSA principles .
Lead the creation of Validation Plans, coordinate risk assessments (Application & Functional), and define test strategies based on assessed risk levels.
Review and approve all validation deliverables: URS, Functional Specs, UAT reports, Validation Summaries, and Authorization for Use (AFU).
Manage validation-related deviations/CAPAs, oversee change controls for validation impact, and conduct GxP Periodic Reviews.
Drive continuous improvement of validation processes, templates, and tools — fix what slows things down.
3. Cross-Functional Collaboration & Training
Partner with IT/Digital, Manufacturing, R&D, and Supply Chain teams to provide GxP guidance during system modernization — team up for Opella's success .
Work with Cybersecurity, Data Privacy, and Internal Audit SMEs to ensure requirements are managed within a unified central framework.
Develop and deliver global training on Digital/GxP policies, Data Integrity, and Validation best practices — building a strong quality culture across the organization.
4. Audit & Inspection Readiness
Oversee end-to-end execution of GxP Periodic Review cycles: scheduling, documentation, evidence collection, and CAPA tracking.
Maintain the validated state of regulated services/systems through Change, Incident, and Problem Management.
Govern digital third-party management: vendor inventories, assessments, quality agreements, and performance monitoring.
Ensure audit and inspection readiness at all times — evidence packages, stakeholder coordination, and post-audit remediation.
Serve as the Subject Matter Expert (SME) during Health Authority inspections (FDA, EMA, MHRA, etc.) for digital systems and data integrity.
Lead CAPA development and effectiveness checks for observations related to digital quality governance.
About You:
We're not just looking for a resume — we're looking for potential, character, and culture fit . You bring deep expertise, but also the mindset of a Challenger: curious, bold, and driven to make things better.
Experience, Education & Skills
10-12 years of hands-on experience in GxP Digital Quality and Compliance, with a strong focus on digital systems and validation.
QA Foundations: Solid background in test strategy, validation lifecycle management, and the GxP aspects of digital systems.
Tooling Proficiency:
Jira & Xray: Experience using Jira/Xray for test management, including test plans, executions, traceability matrices, and dashboards.
Atlassian: Proficiency in managing Jira and Confluence workflows to support compliance processes.
Compliance Systems: Familiarity with ServiceNow, Veeva Vault, and equivalent document management systems.
Regulatory Knowledge: Deep understanding of Annex 11, 21 CFR Part 11, IT General Controls (ITGC), and ALCOA+ data integrity principles.
Experience in GxP supplier qualification activities .
Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
We Are Challengers.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Join us on our mission. Health. In your hands.
www.opella.com/en/careers
