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About the client:

It´s a well-established global pharmaceutical development and licensing company that is expanding its operations into the European Union by setting up a dedicated testing and EU release site in Spain. With over 150 finished products licensed to more than 100 partners across EMEA, APAC, LATAM, and North America, the company is now investing in local infrastructure to offer direct support to its European B2B partners.

Job description:

This new facility will house a state-of-the-art quality control laboratory focused on oral solid dosage forms. As the Qualified Person & Quality Assurance (QP&QA) Manager, you’ll play a central role in building this project from the ground up—developing systems, interacting with authorities, and establishing a new team that will carry forward the company’s commitment to quality and compliance.

What You’ll Do:

• Define and implement the site’s Quality Policy in alignment with GMP and GDP guidelines.
• Establish and maintain a robust, inspection-ready Quality Management System (QMS).
• Review and approve key documentation: CoAs, SOPs, analytical methods, product specs, and work instructions.
• Evaluate batch documentation for manufacturing and packaging to ensure EU GMP and MA compliance prior to release.
• Investigate and manage deviations, OOS/OOT results, CAPAs, and Change Controls.
• Oversee Quality Agreements with CMOs, subcontractors, and B2B clients.
• Act as the company’s representative in regulatory inspections and client audits.
• Lead the qualification and ongoing oversight of CMOs and third-party suppliers.
• Serve as the primary point of contact for quality-related discussions with manufacturers, clients, and regulators.
• Recruit, build, and lead your own Quality and QA team as the site grows and operational needs expand.

Who You Are:

• Degree in Pharmacy and EU-recognized Qualified Person (QP) certification.
• Experienced as a Qualified Person or Deputy QP, or a candidate with a Pharmacy degree and at least 5 years in Quality Assurance within the pharmaceutical industry.
• Deep understanding of EU GMP requirements and quality systems.
• Prior experience with oral solid dosage forms is highly desirable.
• Fluent English speaker, with excellent written and verbal communication skills.
• A hands-on, detail-focused leader with strong problem-solving capabilities.
• Comfortable in a dynamic, entrepreneurial setting where you can make things happen.

Why This Role Is Unique:

• Create something meaningful: Be part of designing and certifying a new EU lab and release site.
• High-impact leadership: Set the quality vision and culture while recruiting and developing your own team.
• Global collaboration: Interact directly with international manufacturers, clients, and regulators.
• Strategic project: High visibility within a stable and globally active pharmaceutical company.
• Professional growth: Competitive compensation, autonomy, and the opportunity to grow with the business.