Quality Assurance

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.

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 Responsibility

• Participate in designing, implementing, maintaining, and improving the quality system. Ensure the QMS is compliant to regulatory requirements
• This role will not only cover the Central Cluster: Romania (Moldova), Hungary, Czech Republic, Slovakia but can be extended to other territories
• Independently initiate and approve SOP updates and creation of new SOPs. Additionally oversee review of SOPs and associated documentation to ensure review requirements are met
• Provide hands on quality expertise to colleagues and partners to support their quality and business needs
• Participate 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 equipment
• Work with QA Director to ensure Medison is compliant with latest regulatory and pharma trends related to GMP and GDP
• Ensure/participate in self-inspections of Medison GMP/GDP operations are performed to schedule and identified CAPA's are closed to plan
• Participate in Medison Management Review to assess the effectiveness of the QMS and to highlight continuous improvements as appropriate
• Ensure 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 required
• Participate in recall and mock recall operations
• Carry out any other duties that may be reasonably required and assigned to you by your manager

Required Education and Experience:

• Master's or Bachelor's Degree in science or equivalent
• At least 5 years' experience in an active QA role
• Excellent written and verbal communication skills
• Fluent English is essential
• Attention to detail
• Quality function representative on various projects
• Root cause analysis and investigation skills
• Technical report writing
• Strong knowledge in regulatory, GDP and GMP requirements
• Proven track record in auditing and quality systems
• Experience in regulatory inspections is desirable
• Strength in critical thinking, problem solving, and decision making
• Collaborative nature, self-directed and independent
• Very strong organizational abilities
• Auditing experience

Required Qualifications:

• Excellent interpersonal skills and ability to successfully maintain professional and trusting relationships
• Works effectively in highly dynamic and changing environments, displays agility
• Willing to travel locally and internationally as needed
• Ability 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 solutions
• Be a quick learner with strong work ethics
• Be pragmatic with a drive for results
• Ability to identify and understand issues, problems and opportunities whilst providing a viable solution
• Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.