Information Technology Quality Assurance Manager

Olon Group is a global leader in the development and production of active pharmaceutical ingredients (APIs) for CDMO and generic markets, integrating chemical synthesis and biological processes while always embracing the highest international safety, quality, and environmental standards.

Olon operates 14 manufacturing sites and 14 R&D centers across the globe.

In order to strengthen the IT team dedicated to Compliance, we are looking for an IT Quality, Compliance and Validation Manager.

Key Responsibilities

• Oversee the entire GxP systems validation lifecycle, ensuring that software and IT infrastructure operate as intended and in compliance with GAMP 5 standards and FDA 21 CFR Part 11 regulations.
• Develop and maintain validation procedures to ensure continuous alignment with current regulatory requirements.
• Prepare, execute, and approve validation protocols and reports (IQ/OQ/PQ).
• Identify, assess, and mitigate risks related to data integrity, cybersecurity, and system performance.
• Provide IT support and quality assessments for deviations and non-conformities.
• Recommend, implement, and oversee corrective and preventive actions (CAPAs) to strengthen IT compliance.
• Author and maintain Standard Operating Procedures (SOPs) and work instructions related to IT system compliance.
• Ensure proper CSV processes during system implementations and offer CSV support for new IT projects throughout the entire project lifecycle.
• Support internal and external audits and inspections, manage interactions with regulatory authorities (e.G., FDA, AIFA), and ensure timely closure of findings through effective CAPA plans.
• Manage user profiling on validated systems, including documentation of profile creation, modification, and deactivation requests, technical implementation, and verification of compliance with requirements.

Required Skills (Hard & Soft Skills)

• Regulatory Knowledge: Solid understanding of GAMP, Annex 11, GxP, and relevant ISO standards.
• Technical Writing: Ability to draft and approve validation protocols, test plans, and final reports.
• Data Analysis: Capability to use analytical tools to monitor quality KPIs and identify trends or deviations.
• Leadership: Strong ability to coordinate cross-functional teams and promote IT quality and compliance culture across the organization.

Your Background and Experience

• A bachelor’s degree or higher.
• A minimum of 3–5 years of experience in a similar role within the Pharmaceutical or Biotech industries, or in specialized consulting firms.
• A detail-oriented mindset and the ability to independently resolve a variety of issues with minimal supervision.
• Strong organizational and planning skills.
• A collaborative approach and ability to work effectively in team environments.
• Excellent English communication skills (verbal, written, and interpersonal).

You will find: