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 ResponsibilitiesOversee 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.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.Required Skills (Hard & Soft Skills)Regulatory Knowledge: 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 ExperienceA 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.Excellent English communication skills (verbal, written, and interpersonal).A dynamic, constantly evolving work environment, open to creativity and personal contribution Training Program to increase your personal and professional skills Courses for recent high school graduates and graduates Internal career paths: we believe in internal growth and cultivate our managers An inclusive environment that fosters integration of different cultures and mindsetsOlon is committed to providing equal opportunities in employment. Our policy foresees that equal employment opportunities are provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status and/or any legally recognized status entitled to protection under applicable local laws.#