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Opella

Global OTC & VMS self-care manufacturer

Quality and Project Platforms Lead

IT OperationsPosted on Nov 14
Full-timeHyderabad, Telangana, IndiaNo salary listedIn-person

About the Job

Requirements

  • 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.
  • At least 3 to 5 years of people-management experience, ideally managing senior specialists and platform owners in a flat structure, including hiring, coaching, performance management, and leading work delivered through partners.
  • Experience owning an enterprise SaaS platform, including its roadmap, budget, vendors, lifecycle, adoption, and service levels.
  • Knowledge of test strategy, test management, automation, and the validation lifecycle for GxP digital systems.
  • Hands-on experience with Jira and Xray for test plans, executions, traceability matrices, and dashboards.
  • Understanding of how Tricentis Tosca automation is designed, maintained, and scaled in a large system landscape.
  • Ability to configure and govern Jira and Confluence Cloud, including workflows, permissions, apps, administration, and security controls.
  • Familiarity with ServiceNow, Veeva Vault, or equivalent document management systems.
  • Knowledge of GxP, ICH guidelines, HIPAA, 21 CFR Part 11, GAMP 5, CSA, IT general controls, and ALCOA+ data integrity principles.
  • Experience running GxP supplier qualification activities.
  • Fluency in English and comfort working with stakeholders across a global matrix organization.

Responsibilities

  • Lead and line manage 5 to 10 experts and platform owners, including internal staff and partner resources; set direction and priorities across digital quality, testing, and platforms.
  • Assign platform owners clear accountability, decision rights, and roadmaps, and hold them accountable for delivery.
  • 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 platform budgets and vendor relationships.
  • Build one team culture across quality, testing, and platform engineering.
  • Own global GxP-relevant Digital Quality policies, standards, standard operating procedures, work instructions, and the Digital Control Framework, including control design, ownership, effectiveness testing, evidence retention, and remediation tracking.
  • Oversee controlled document management for computer system validation and computer software assurance, data integrity under ALCOA+, cloud and software-as-a-service governance, and electronic records and signatures under 21 CFR Part 11.
  • Ensure digital solutions meet GxP, ICH, HIPAA, and 21 CFR Part 11 requirements, including requirements for protected health and personal data across regulated and commercial systems.
  • Provide quality oversight for computer system validation using GAMP 5 and computer software assurance principles; make and document risk-based decisions.
  • Govern validation plans, risk assessments, and test strategies; review and approve user requirements specifications, functional specifications, user acceptance testing reports, validation summaries, and Authorization for Use.
  • Manage validation deviations and corrective and preventive actions, oversee change controls for validation impact, and conduct GxP periodic reviews.
  • Govern digital supplier management, including vendor inventories, assessments, quality agreements, and performance monitoring.
  • Own global testing strategy and standards across functional, integration, regression, performance, and user acceptance testing for GxP and non-GxP systems.
  • Own Xray as the test management layer in Jira and Tricentis Tosca as the automation platform, covering roadmaps, licensing, environments, upgrades, integrations, and adoption through platform owners.
  • Grow automation coverage on priority systems such as ERP, supply chain, commercial, and web systems, and make automated evidence usable for validation where regulations allow.
  • Maintain traceability from requirements to test cases, execution, and defects; define testing metrics such as coverage, defect leakage, automation rate, and cycle time, and use them to improve team practices.
  • Engage project and product teams early so testing is planned from the start.
  • Own Jira and Confluence on Atlassian Cloud, Jira Service Management, the Marketplace app portfolio, and integrations with the digital toolchain.
  • Define and govern project templates, workflows, schemes, permissions, and space structures to support agile delivery and regulated-environment traceability.
  • Plan the Atlassian platform roadmap for 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 controls for GxP-relevant records in Jira and Confluence.
  • Drive adoption and standardization across Digital and business functions, and run platform operations to agreed service levels with a clear support model and incident and problem management.
  • Partner with Digital, Manufacturing, R&D, Quality, and Supply Chain teams to provide GxP and testing guidance during system modernization.
  • Coordinate with Cybersecurity, Data Privacy, and Internal Audit specialists so requirements are managed through one central framework.
  • Build and deliver global training on digital and GxP policies, data integrity, validation, testing, and Atlassian practices.
  • Maintain audit-ready evidence packages and stakeholder coordination; act as subject matter expert during Health Authority inspections and internal or external audits covering digital systems, validation, and data integrity.
  • Lead corrective and preventive action development and effectiveness checks for findings related to digital quality governance.

About the Company

Opella

Global OTC & VMS self-care manufacturer

Opella makes a wide range of over-the-counter medicines, vitamins, minerals, and supplements for global consumers, covering about 100 brands and an 11,000-strong workforce. It develops, manufactures, and markets non-prescription health products that people can buy ready-made in stores for common needs such as pain relief, digestion, and allergy relief. The company differentiates itself with a large global manufacturing footprint (13 sites and 4 science and innovation centers) and its B Corp certification, signaling accountability to social and environmental standards. Its goal is to simplify self-care and put health in people’s hands for half a billion consumers worldwide.

Company size
5,001-10,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Neuilly-sur-Seine, France
Founded
2018

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