Qualification Team Lead

Qualification Team Lead Apply now Are you ready to take the lead on validation activities in a dynamic, international pharmaceutical environment? As a Qualification Team Leader, you’ll ensure systems, equipment, and processes stay compliant and inspection-ready in line with Abacus Medicine Global’s validation policy across all GxP areas, while continuously strengthening quality standards and ways of working. If you enjoy combining leadership with regulatory expertise and innovative thinking, and want to make a real impact in a growing global organization, this could be your next step. The opportunity In this role, you will lead a team of 7 and play a key part in defining and advancing global validation strategies. You’ll oversee impactful projects from initial risk assessment through production acceptance testing and implementation, working closely with cross-functional stakeholders including Digital, QA, project teams, and international partners. We would like you to: Create/review/approve and track the status of qualification and validation documents for various systems/equipment/processes located in Abacus Medicine's and its contracted partners' facilities. Create and maintain global validation/qualification master plans and document systems, scheduling annual validation and qualification activities. Support change control for critical processes and equipment by implementing an efficient and effective revalidation program across all cGMP facilities, and manage equipment and computerized system change verification to ensure all systems remain in a validated state. Participate in the implementation of a project that will affect the validation status of any system/equipment/process: Preliminary evaluation; Developing requirements, mapping and assessing risks; Perform a factory acceptance test at the carrier's site; On-site training & support Support and participate in cross-functional projects. Lead and manage the validation team (organizing the working time of direct subordinates, task management, annual performance evaluation, etc.). Preparation of the quality management report every six months. Onboard new employees in the department globally and participating in the training of employees in the field of quality assurance (new entrants). Write/review specifications, instructions, procedures, and monitor their effectiveness. Participate in internal audits and official audits as instructed by the assigned quality management person or QA Operation Manager. Manage and maintain quality assurance records. Monitor compliance with GMP (Good Manufacturing Practice) requirements. Support of other AM sites in validation/qualification issues (with travel abroad, on a case-by-case basis). What we need you to have: Bachelor’s or university degree in Pharmacy, Engineering, or a related field Minimum 5 years of experience in a GxP-regulated environment 3+ years of experience in leading teams, including hands-on people management Expert-level knowledge of EU-GxP requirements Strong understanding of pharmaceutical manufacturing processes English language proficiency at minimum B2 level What we offer: Support for work-life balance, flexible management approach; Abacus is a long-term opportunity, we encourage your professional development with internal job opportunities and trainings; Semi-annual company bonus; Cafeteria with optional elements; Annual salary increase; Employee referral program with high rewards; AYCM SportPass membership opportunity; Private health insurance package provided by Medicare after 6 months of employment. Are you interested? If you want to apply, please use the apply link and attach your resumé. We look forward to receiving your application! Moving Healthcare. Moving You. In Abacus Medicine Group, you’ll experience the power of Moving Healthcare. With our change mindset, we're moving the industry and improving healthcare as we broaden access to medicine. But it's not just about moving healthcare, it's about Moving You. You’ll be part of a caring community of more than 1,300 people across the World. With us, you will be valued, empowered, and have a direct impact on driving change. Let's access the future of medicine and make a difference together. Your move. Department Quality Assurance Locations Budapest - Maglódi út 6 Remote status Hybrid Employment type Full-time