Position: Global Quality Assurance Manager

Location:
Madrid

Experience:
10+ years of experience in Quality Management Systems within the pharmaceutical, biotechnology, or medical device industry Contract: Permanent INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and expertise in scientific research, development, manufacturing, sales, and marketing of a wide range of pharmaceutical active ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, delivering added value for human and animal health. Industrial (Chemo), Branded (Exeltis), with 10,000 professionals across more than 50 countries, 20 industrial plants, 15 specialized R&D; centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in over 110 countries worldwide. We are looking for a Global Quality Assurance Manager to lead the strategic development, implementation, continuous improvement, and global oversight of our enterprise-wide Quality Management System (QMS). International regulatory requirements, including US FDA, EU regulations, and other applicable global standards. The successful candidate will play a key role in driving harmonization and standardization of quality processes across global sites, while fostering a strong culture of quality excellence and continuous compliance. We are looking for a strategic and hands-on quality leader with strong global experience in highly regulated environments, capable of driving transformation, compliance, and operational excellence across the organization. Develop, implement, and maintain a comprehensive global QMS strategy aligned with business objectives, regulatory requirements, and industry best practices. Ensure the QMS is fully compliant with US FDA,



EU regulations, and other applicable global requirements. Lead global initiatives to harmonize and standardize quality processes such as CAPA, Deviations, Change Control, Document Control, Training, Audits, Complaints, Supplier Quality, and Product Release across manufacturing, R&D;, and commercial sites. Develop and implement global SOPs, policies, and work instructions related to QMS elements. Proactively monitor changes in global quality regulations such as 21 CFR and EudraLex, ensuring the QMS is updated accordingly. Collaborate closely with IT and QMS software owners, including platforms such as TrackWise Digital and LIMS, to ensure digital quality tools support compliance with 21 CFR Part 11 and EudraLex Annex 11 requirements for electronic records and signatures. Oversee QMS software validation activities to ensure GxP compliance. Prepare and present QMS performance reports to senior management during Management Reviews. Integrate robust risk management principles across QMS processes to proactively identify, assess, and mitigate quality risks. Support the strategic development of an effective global risk-based audit strategy and program. Support the establishment, implementation, and maintenance of the global audit program covering suppliers, contract manufacturers, and internal operations in compliance with GxP regulations (GMP, GDP, GCP) and corporate quality policies. Monitor audit progress,



closure of findings, and overall compliance trends, providing periodic reports for management review. Collaborate with site QA teams, Regulatory Affairs, Procurement, and other stakeholders to ensure alignment of the audit program with business and compliance needs. Maintain a qualified pool of auditors by supporting auditor training, qualification, and performance assessment. Manage third-party audit service activities and ensure full compliance of these activities with GxP regulations and corporate quality policies. Develop, implement, and maintain the supplier qualification program in line with global regulatory requirements such as EMA, FDA, ISO 9001, and internal quality standards. Lead and oversee supplier selection, qualification, and requalification processes for global suppliers. Develop and oversee global QMS training programs to ensure all personnel are appropriately trained on QMS procedures and regulatory requirements. Champion a strong quality culture across the organization, promoting continuous improvement, accountability, and quality excellence at all levels. Contribute to the Integral Quality Learning Program and the Global Quality Culture Program. Collaborate in the creation, management, and reporting of global and site-specific project plans. Integrate into, contribute to, and/or lead cross-functional project teams, supporting project schedules as needed. Lead, mentor, and develop a team of Quality Systems specialists/analysts, fostering a collaborative and high-performing environment focused on global quality excellence. Additional training or significant exposure to healthcare, Quality Assurance, or Quality Control will be considered a plus. Fluent Engli

📌 Quality Assurance Coordinator (Madrid)
🏢 Insud Pharma
📍 Madrid