In brief 📌

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 Global 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 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 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.
• 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 EudraLex, 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 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.
• 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 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.
• Perform supplier, corporate, and customer audits when required.
• 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 Global 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.

What do you need? 🤓

• University degree in Chemistry, Pharmacy, or another relevant Science / Engineering discipline.
• Additional training or significant exposure to healthcare, Quality Assurance, or Quality Control will be considered a plus.
• Fluent English is required.
• Spanish will be considered an asset.
• Minimum 10+ years of progressive experience in Quality Management Systems within the pharmaceutical, biotechnology, or medical device industries.
• Proven track record in managing global QMS.
• Extensive and demonstrable expertise in interpreting and implementing FDA 21 CFR regulations and EudraLex requirements.
• Strong background in leading and managing global QMS elements such as CAPA, Change Control, Deviations, Document Control, Training, and Audit Management.
• Proven experience preparing for major regulatory inspections such as FDA and EMA, as well as third-party audits.
• Experience working with digital QMS platforms, such as TrackWise Digital System, including implementation, validation, and administration.
• Deep understanding of GxP principles (GMP, GCP, GLP) and ISO standards such as ISO 9001 and ISO 13485.
• Proficiency in quality risk management methodologies.
• Familiarity with data integrity principles and their application in QMS.
• Understanding of computer system validation (CSV) methodologies, such as GAMP 5.
• Availability to travel approximately 15% of the time, with the possibility of an increase depending on business needs.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent cross-cultural communication, negotiation, and interpersonal skills, with the ability to engage effectively with diverse global stakeholders at all levels.
• Strong project management capabilities, including planning, execution, and monitoring of complex initiatives.
• High level of attention to detail, precision, and commitment to accuracy.
• Ability to manage interpersonal conflicts and promote a collaborative working environment.

Preferred qualifications ⭐

• Specific CSV training, such as GAMP 5 certification.
• Willingness to work with emerging technologies, including AI and data analytics in the Quality environment.
• Familiarity with agile working methodologies and digital transformation frameworks.

🔷Do you think this role is not for you? 🔷

Follow us on LinkedIn and Instagram to stay updated on future career opportunities at Insud Pharma.
#InsudPharma #Challenger #Insuder #InsudTalent

Equal Opportunity Commitment

At Insud Pharma, we are committed to equal opportunity and to building a diverse, inclusive, and respectful workplace. All applications will be considered without discrimination based on gender, gender identity or expression, sexual orientation, age, ethnicity, nationality, religion, disability, or any other personal or social condition, ensuring selection processes based on merit, capability, and experience.