Quality Assurance System Manager

In a few words Position: Quality Assurance System Manager Location: Madrid (On site) Experience: Minimum 8 years’ experience with solid knowledge in mainly QA, QC and GMP related activities. Ready to lead the future of Quality? Insud Pharma is hiring a Global Quality Systems Manager to drive our digital transformation journey across a truly global Quality organization. About the role: Ready to be a Challenger? This individual will lead a global team focused on computerized system validation (CSV), TrackWise Digital system management, and support the broader digital transformation journey within the Quality function of our pharmaceutical company. The role will ensure that all digital quality systems meet regulatory compliance standards while driving innovation, efficiency, and excellence across our global Quality operations. QA Systems Manager is responsible for: Leadership & Strategy: Lead a global team specializing in Computerized System Validation (CSV) and Quality digital systems management. Define and drive the digital strategy for Quality systems in alignment with overall corporate digital transformation goals. Serve as the global business owner for TrackWise Digital and other Quality systems. Computerized System Validation: Oversee the full lifecycle of GxP computerized system validation activities, ensuring compliance with global regulatory standards (FDA 21 CFR Part 11, EU Annex 11, GAMP 5). Develop and maintain global CSV policies, procedures, and templates. Act as subject matter expert during audits and regulatory inspections related to digital quality systems. Digital Systems Management: Manage and optimize the TrackWise Digital Quality Management System (QMS) and other related platforms. Ensure system configuration, performance, and user support meet global operational needs. Collaborate with IT, Quality Operations, and Regulatory Affairs to ensure system alignment, upgrades, and new deployments. Digital Transformation & Innovation: Lead initiatives to identify, pilot, and implement new digital tools and technologies in Quality operations. Champion a culture of digital adoption, training, and change management within the Quality community. Compliance & Risk Management: Ensure that digital systems remain compliant with applicable GxP regulations and internal standards. Proactively identify risks and drive corrective and preventive actions (CAPAs) related to system compliance and performance. What do you need? Education: University Level in Chemistry, Pharmacy or other relevant Science / Engineering discipline, with significant training / exposure, healthcare or specific to Quality Assurance / Quality Control is an advantage. Languages: Fluent Spanish, English, knowledge of other languages will be an asset. Experience (years/area): 8 years of experience in the pharmaceutical or biotechnology industry, preferably within Quality Assurance and/or Computerized Systems. Specific Knowledge: Strong knowledge of GxP regulatory requirements and industry standards for computerized systems. Proven experience managing TrackWise Digital or similar enterprise Quality Management Systems. Travels: about 15% of the time, though this percentage may be increased. Personal skills: Solid leadership and team management skills in a global environment. Excellent communication, stakeholder management, and project execution skills. Preferred Qualifications: Project Management (PMP) or CSV specific training (e.g., GAMP 5 certification). Experience introducing emerging technologies (AI, data analytics) in the Quality space. Familiarity with agile working methodologies and digital transformation frameworks. ‍‍ Why Join Us? Play a critical role in shaping the future of Quality at a leading global pharmaceutical company. Lead cutting-edge digital initiatives that impact healthcare worldwide. Work with diverse, passionate teams across continents. Access outstanding opportunities for growth and professional development. Make a real impact on patient lives around the globe. ✨ Join us at Insud Pharma and be part of a company where innovation, purpose, and excellence drive everything we do. Let’s shape the future of healthcare together. Apply now! QA Systems Manager in MADRID, Spain | INSUD PHARMA, S.L.U. What will the Selection process be like? ➡Stay tuned to your phone and email! The first thing we will likely do is contact you through one of the two channels. ➡Prepare well! We will continue with an in-person/virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and depending on the type of process, there may also be some kind of test. ➡Wait for the result! We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process. COMMITMENT TO EQUAL OPPORTUNITIES Insud Pharma is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3/2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.

Location: es, ES

Posted Date: 5/1/2025