Quality Assurance (QA) Manager

Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live.Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve.We are a dynamic, fast-paced company, operating in over 34 countries across 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us!As QA Manager for Central EPM (European Partner Markets), you’ll be a key player in safeguarding quality across multiple European markets, ensuring our operations meet the highest regulatory standards and drive continuous improvement.Responsibilities:The Quality Assurance Manager, Central EPM is an experienced professional and part of European Partner Markets (EPM) QA team. Based in Romania, as part of the Central Cluster, the QA Manager is supporting a number of territories, and will report directly to the Head of QA, EPM. He/she will play a vital role in the Region as well as actively participate in the EPM Quality Team.Areas of ResponsibilityParticipate in designing, implementing, maintaining, and improving the quality system. Ensure the QMS is compliant to regulatory requirementsThis role will not only cover the Central Cluster: Romania (Moldova), Hungary, Czech Republic, Slovakia but can be extended to other territoriesIndependently initiate and approve SOP updates and creation of new SOPs. Additionally oversee review of SOPs and associated documentation to ensure review requirements are metProvide hands on quality expertise to colleagues and partners to support their quality and business needsParticipate in vendor management program, vendor oversight, QTA generation and auditing including lead auditor role to evaluate partner/vendor’s Quality Management Systems, resources, premises, and equipmentWork with QA Director to ensure Medison is compliant with latest regulatory and pharma trends related to GMP and GDPEnsure/participate in self-inspections of Medison GMP/GDP operations are performed to schedule and identified CAPA’s are closed to planParticipate in Medison Management Review to assess the effectiveness of the QMS and to highlight continuous improvements as appropriateEnsure change control requests, deviations, complaints and CAPA’s are reviewed using risk-based principles to comply with applicable requirements Participate in regulatory inspections and supplier audits as requiredParticipate in recall and mock recall operationsCarry out any other duties that may be reasonably required and assigned to you by your managerRequirements:Required Education and Experience:Master’s or Bachelor’s Degree in science or equivalentAt least 5 years’ experience in an active QA roleExcellent written and verbal communication skillsFluent English is essentialAttention to detailQuality function representative on various projectsRoot cause analysis and investigation skillsTechnical report writingStrong knowledge in regulatory, GDP and GMP requirementsProven track record in auditing and quality systemsExperience in regulatory inspections is desirableStrength in critical thinking, problem solving, and decision makingCollaborative nature, self-directed and independentVery strong organizational abilitiesAuditing experienceRequired Qualifications:Excellent interpersonal skills and ability to successfully maintain professional and trusting relationshipsWorks effectively in highly dynamic and changing environments, displays agilityWilling to travel locally and internationally as neededAbility to work with anyone (flexible personality) horizontally and vertically across the organization with a demonstrated ability to interact professionally, to influence, and to manage conflict/differing opinions with the ability to drive solutionsBe a quick learner with strong work ethicsBe pragmatic with a drive for resultsAbility to identify and understand issues, problems and opportunities whilst providing a viable solutionAble to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.