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Quality Assurance

3 weeks ago

București Israel Medison Pharma Full time

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

We're hiring QA Manager in Romania

As Quality Assurance Manager, you'll play a pivotal role in ensuring our operations meet the highest regulatory standards and deliver exceptional quality across your market. In this position, you will lead compliance efforts, drive continuous improvement, and support processes that make a real impact on patients and partners.

The Quality Assurance Manager in Central Cluster (Romania, Moldova, Hungary, Czech Republic, Slovakia) will oversee quality operations to ensure compliance with regulatory standards, support continuous improvement initiatives, and manage QA activities while reporting directly to the Head of QA, EPM, actively contributing to regional and EPM-wide quality strategies.

Core Responsibilities:

  • Design, implement, maintain, and continuously improve the Quality Management System (QMS) to ensure compliance with regulatory requirements.
  • Independently initiate, review, and approve SOP updates; create new SOPs and oversee periodic review of associated documentation.
  • Provide hands-on quality expertise to colleagues and partners to support business and compliance needs.
  • Participate in vendor management programs, including vendor oversight, QTA generation, and auditing (acting as lead auditor when required) to evaluate partner/vendor QMS, resources, premises, and equipment.
  • Collaborate with QA leadership to ensure compliance with the latest GMP/GDP regulations and pharmaceutical trends.
  • Ensure and participate in self-inspections of Medison GMP/GDP operations, ensuring CAPAs are closed according to plan.
  • Contribute to Medison Management Reviews to assess QMS effectiveness and identify continuous improvement opportunities.
  • Review change control requests, deviations, complaints, and CAPAs using risk-based principles to comply with applicable requirements.
  • Participate in regulatory inspections, supplier audits, recalls, and mock recall operations.
  • Perform any other duties reasonably required and assigned by your manager.

Required Education and Experience:

  • Master's or Bachelor's degree in Science or equivalent
  • Minimum 5 years of experience in an active QA role within the healthcare or pharmaceutical sector
  • Strong knowledge of regulatory requirements, including GDP and GMP
  • Proven track record in auditing and quality systems, including experience as a quality auditor; experience in regulatory inspections is desirable
  • Ability to act as a quality function representative on various projects
  • Expertise in root cause analysis, investigations, and technical report writing
  • Experience in SOP creation and updates, as well as other quality documentation
  • Excellent written and verbal communication skills; fluent English is essential
  • Strong critical thinking, problem-solving, and decision-making skills
  • High attention to detail and strong organizational abilities
  • Collaborative, self-directed, and able to work independently.

Required Qualifications:

  • Excellent interpersonal skills with the ability to build and maintain professional, trusting relationships
  • Strong ability to work effectively in highly dynamic and changing environments; demonstrates agility and adaptability
  • Willingness to travel locally and internationally as needed
  • Flexible personality with the ability to collaborate horizontally and vertically across the organization; capable of influencing, managing conflict, and driving solutions
  • Quick learner with strong work ethic and pragmatic approach focused on results
  • High attention to detail and strong organizational abilities
  • Ability to identify and understand issues, problems, and opportunities while providing viable solutions
  • Able to work in a fast-paced, dynamic environment and adjust readily to meet unexpected constraints.