Opella
Website:
opella.com
Job details:
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) and Vitamins, Minerals and 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 role
You will lead a team of 5 to 10 experts and platform owners covering three connected areas:
Digital Quality, meaning GxP processes, computer system validation, and the Digital Control Framework.
Testing and quality engineering, including test strategy, test management and automation on Xray and Tricentis Tosca.
The Atlassian platform, where Jira and Confluence on Atlassian Cloud carry project delivery, documentation and compliance evidence for Opella Digital.
The role is both platform owner and people manager. There is no intermediate management layer, so you lead senior specialists directly and stay close enough to the work to challenge a validation rationale, review a test automation approach, or settle a Jira workflow design.
We are looking for someone with 12 to 15 years of experience who owns the outcome rather than the task, simplifies processes that have grown complicated, and works comfortably across Digital, Quality and the business functions.
What you will do
Lead the team
Line manage 5 to 10 experts and platform owners, including internal staff and partner resources. Set direction and priorities across three areas at once. Give each platform owner clear accountability, decision rights and a roadmap they own, then hold them to it. Run objective setting, performance and development conversations, coaching, and skills, backup and succession planning. Shape resourcing, capacity and the balance between insourced and partner-delivered work. Own the budget and vendor relationships for the platforms in scope. Build one team culture across quality, testing and platform engineering rather than three separate groups.
Digital Quality, policy and validation governance
You are the global owner for GxP-relevant Digital Quality policies, standards, SOPs and work instructions, and for making them usable in practice. You own the Digital Control Framework: control design, control ownership, testing of control effectiveness, evidence retention and remediation tracking.
The role covers controlled document management for CSV and CSA, data integrity under ALCOA+, cloud and SaaS governance, and electronic records and electronic signatures under 21 CFR Part 11. Digital solutions must meet GxP, ICH, HIPAA and 21 CFR Part 11 requirements, including how protected health and personal data is handled across regulated and commercial systems.
You provide quality oversight for computer system validation using GAMP 5 and CSA principles, take risk-based decisions and document the reasoning. You govern validation plans, risk assessments and test strategies, and you review and approve URS, functional specifications, UAT reports, validation summaries and Authorization for Use. You manage validation deviations and CAPAs, oversee change controls for validation impact, and run GxP periodic reviews. You also govern digital supplier management: vendor inventories, assessments, quality agreements and performance monitoring.
Testing, strategy, tooling and delivery assurance
Own the global test strategy and testing standards for Opella Digital across functional, integration, regression, performance and user acceptance testing, in both GxP and non-GxP systems. You are accountable for Xray as the test management layer in Jira and for Tricentis Tosca as the automation platform, covering roadmap, licensing, environments, upgrades, integrations and adoption, working through the platform owners in your team.
Grow automation coverage on the systems that matter most, such as ERP, supply chain, commercial and web, and make automated evidence usable for validation where the regulations allow it. Keep traceability intact from requirement to test case to execution to defect, which serves delivery quality and inspection readiness at the same time. Set testing metrics such as coverage, defect leakage, automation rate and cycle time, and use them to change how the teams work. Get involved early enough with project and product teams that testing is planned in from the start rather than added at the end.
Atlassian platform
Own Jira and Confluence on Atlassian Cloud, along with Jira Service Management, the Marketplace app portfolio and the integrations with the rest of the digital toolchain. Define and govern project templates, workflows, schemes, permissions and space structures so that they support agile delivery and the traceability a regulated environment needs.
Cloud releases arrive continuously, so the platform roadmap has to cover release and change management, app rationalization, performance, cost and license optimization. Work with Cybersecurity, Identity and Internal Audit on security, privacy, access management, data residency and audit requirements, including the controls needed for Jira and Confluence to hold GxP-relevant records. Drive adoption and standardization across Digital and the business so the standard way is also the easy way, and run platform operations to agreed service levels with a clear support model and incident and problem management.
Collaboration, audit and inspection readiness
Partner with Digital, Manufacturing, R&D, Quality and Supply Chain teams to give GxP and testing guidance during system modernization. Work with Cybersecurity, Data Privacy and Internal Audit specialists so requirements are managed in one central framework rather than several. Build and deliver global training on digital and GxP policies, data integrity, validation, testing and Atlassian practices.
Keep evidence packages and stakeholder coordination ready for audit at any time, not only when one is announced. Act as the subject matter expert during Health Authority inspections (FDA, EMA, MHRA and others) and internal or external audits covering digital systems, validation and data integrity, and lead CAPA development and effectiveness checks for findings related to digital quality governance.
About you
We look at potential, character and culture fit alongside experience.
You have 12 to 15 years of experience across digital quality and compliance, software testing and platform ownership in a regulated industry such as pharma, healthcare or life sciences.
You have managed people for at least 3 to 5 years, ideally senior specialists and platform owners in a flat structure, including hiring, coaching, performance management and leading work delivered through partners.
You have owned an enterprise SaaS platform yourself, including its roadmap, budget, vendors, lifecycle, adoption and service levels.
You know test strategy, test management, automation and the validation lifecycle for GxP digital systems.
On tooling, you have worked hands on with Jira and Xray for test plans, executions, traceability matrices and dashboards. You understand how Tricentis Tosca automation is designed, maintained and scaled in a large system landscape. You can configure and govern Jira and Confluence Cloud, including workflows, permissions, apps and admin and security controls. You are familiar with ServiceNow, Veeva Vault or equivalent document management systems.
On regulation, you know GxP, ICH guidelines, HIPAA and 21 CFR Part 11 for electronic records and signatures, together with GAMP 5, CSA, IT general controls and ALCOA+ data integrity principles. You have run GxP supplier qualification activities.
You are fluent in English and comfortable working with stakeholders across a global matrix organization.
The Opella leadership behaviors we are looking for
We assess every candidate against our four behaviors.
Behavior What it looks like in this role All in. Together. You lead one team across quality, testing and platforms, and you partner across Digital, R&D, Manufacturing and Supply Chain, asking for help and giving it freely. Courageous You challenge how validation and testing are done today, take considered risks on automation and platform change, and speak up during inspections. Outcome-Obsessed You own the compliance and delivery result, not only the task, and follow through with integrity and speed. Radically Simple You make GxP frameworks and platform configurations simple enough for teams to understand and apply.
Opella is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment where every candidate feels respected.
Click on Apply to know more.
