PpOlon 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. /ppOlon operates 14 manufacturing sites and 14 RD centers across the globe. /ppIn order to strengthen the IT team dedicated to Compliance, we are looking for an bIT Quality, Compliance and Validation Manager /b. /ph3Key Responsibilities /h3ulliOversee 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. /liliDevelop and maintain validation procedures to ensure continuous alignment with current regulatory requirements. /liliPrepare, execute, and approve validation protocols and reports (IQ/OQ/PQ). /liliIdentify, assess, and mitigate risks related to data integrity, cybersecurity, and system performance. /liliProvide IT support and quality assessments for deviations and non-conformities. /liliRecommend, implement, and oversee corrective and preventive actions (CAPAs) to strengthen IT compliance. /liliAuthor and maintain Standard Operating Procedures (SOPs) and work instructions related to IT system compliance. /liliEnsure proper CSV processes during system implementations and offer CSV support for new IT projects throughout the entire project lifecycle. /liliSupport 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. /liliManage user profiling on validated systems, including documentation of profile creation, modification, and deactivation requests, technical implementation, and verification of compliance with requirements. /li /ulh3Required Skills (Hard Soft Skills) /h3ullibRegulatory Knowledge: /b Solid understanding of GAMP, Annex 11, GxP, and relevant ISO standards. /lilibTechnical Writing: /b Ability to draft and approve validation protocols, test plans, and final reports. /lilibData Analysis: /b Capability to use analytical tools to monitor quality KPIs and identify trends or deviations. /lilibLeadership: /b Strong ability to coordinate cross-functional teams and promote IT quality and compliance culture across the organization. /li /ulh3Your Background and Experience /h3ulliA bachelor’s degree or higher. /liliA minimum of b3–5 years of experience /b in a similar role within the Pharmaceutical or Biotech industries, or in specialized consulting firms. /liliA detail-oriented mindset and the ability to independently resolve a variety of issues with minimal supervision. /liliStrong organizational and planning skills. /liliA collaborative approach and ability to work effectively in team environments. /liliExcellent English communication skills (verbal, written, and interpersonal). /li /ulh3You will find: /h3ulli /ul /li /p