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 Want to know more? 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.

Insud Pharma is organized into three synergistic business areas: 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. Insud Pharma believes in innovation and sustainable development.

We are looking for a General Quality Assurance Manager to lead the strategic development, implementation, continuous improvement, and global oversight of our enterprise-wide Quality Management System (QMS). This role is critical to ensuring that our QMS is robust, scalable, and fully compliant with i 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. What are we looking for? 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. The challenge

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. Oversee the full QMS lifecycle, including design, implementation, maintenance, and continuous improvement.

Lead general 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. Act as a key subject matter expert during internal and external audits, including FDA inspections, EMA inspections, notified body audits, and ISO audits.

Proactively monitor changes in global quality regulations such as 21 CFR and Eudra Lex, ensuring the QMS is updated accordingly. Manage and track regulatory commitments related to QMS observations or deficiencies. Collaborate closely with IT and QMS software owners, including platforms such as Track Wise Digital and LIMS, to ensure digital quality tools support compliance with 21 CFR Part 11 and Eudra Lex Annex 11 requirements for electronic records and signatures.



Oversee QMS software validation activities to ensure Gx P compliance.

Establish and monitor KPIs and metrics to assess QMS effectiveness, efficiency, and compliance. Prepare and present QMS performance reports to senior management during Management Reviews. Lead and facilitate periodic QMS reviews to ensure ongoing suitability and effectiveness. Integrate robust risk management principles across QMS processes to proactively identify, assess, and mitigate quality risks. Ensure risk-based approaches are applied to QMS design, validation, and maintenance activities.

Support the strategic development of an effective general 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 Gx P 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. Perform supplier, corporate, and customer audits when required. Manage third-party audit service activities and ensure full compliance of these activities with Gx P 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 suppli

📌 Global Quality Assurance Manager (Madrid)
🏢 Insud Pharma
📍 Madrid