Quality Assurance

hace 5 días

Madrid, España Actual Talent Spain A tiempo completo

Actual Talent is the talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions. Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through talent acquisition and development solutions that focus on people, diversity and inclusion, innovation, and cutting-edge technology. About the Project We are partnering with a high-growth Biotechnology company (global "scale-up" phase.) that is currently disrupting its therapeutic area with the global launch of an innovative biological drug. Quality Assurance Manager & Qualified Person Your mission will be to ensure that the global expansion of our product meets the highest quality standards by supervising external manufacturing and leading the batch release process to the market. Your Key Challenges : Act as the Qualified Person (QP) taking legal responsibility for the certification and release of every manufactured batch (GMP / GDP). Lead the technical relationship with international CMOs ensuring that external production consistently adheres to the company's quality standards. Supervise the entire product lifecycle : from manufacturing changes to resolving quality incidents, deviations, and OOS. Ensure regulatory compliance across the new markets where the drug is being deployed globally. Represent the company before Health Authorities inspections, audits, and official communications). What We Are Looking For Education : Bachelor’s Degree in Pharmacy (legal requirement for the QP role). A Master’s degree in the Pharmaceutical Industry is a plus. Experience : At least 3-5 years in QA departments, with proven previous experience acting as a Qualified Person (QP) Expertise : Solid experience with biological products, biotechnological drugs, or sterile injectables aseptic processing, Annex 1). Languages : Advanced level of English essential for daily communication with international suppliers and stakeholders). Mindset : We are looking for someone who thrives in dynamic environments, with strong decision-making skills and a high orientation toward quality and detail. What This Project Offers The chance to be a key player in the success of an expanding Biotech with a global footprint. Direct responsibility over a high-complexity scientific product. A professional, agile, and internationally focused work environment. #J-18808-Ljbffr

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