Quality manager

Dear future colleague!

We are looking to welcome a talented Quality Manager to our Ukrainian team!

COREX Logistics is an international clinical trial supply and logistics company that provides innovative solutions for the pharmaceutical and biotechnology sectors. COREX prides itself on attracting the most talented and best people to its dynamic team. At COREX, you will find challenges, inspiration, support and rewards for your work. By joining the COREX team, you will have the opportunity to play a vital role in ensuring our clients' success and, ultimately, in improving people’s lives around the world.

COREX Logistics operates across several regions in Central and Eastern Europe and the CIS. Our international headquarters are located in Dublin, Ireland.

Main responsibilities:

• Maintain, implement, and continuously improve the Quality Management System (QMS) for all company operations within Ukraine.
• Ensure that all activities are performed in compliance with:  Ukrainian Ministry of Health (MoH) regulations, applicable local pharmaceutical legislation, Good Distribution Practice (GDP 2013/C 343/01), internal company quality policies and procedures. ?
• Act as the primary quality lead for Ukraine, providing regular reporting to the CEO on quality performance, compliance risks, deviations, CAPAs, and continuous improvement initiatives.
• Review, update, and maintain Standard Operating Procedures (SOPs), work instructions, templates, and quality documentation, ensuring that process owners develop SOPs for their respective functions and that all documentation remains current and compliant with local requirements.
• Ensure that only authorized product categories are procured from approved suppliers and supplied to approved customers in accordance with the Company’s wholesale distribution authorization and local licensing requirements.
• Perform quality oversight of procurement, storage, and distribution activities through internal audits, self-inspections, deviation review, and trend monitoring.
• Conduct and maintain supplier and customer qualification processes.
• Lead and coordinate complaint handling, deviations, investigations, returns, and recall processes, ensuring timely root cause analysis and documentation.
• Manage CAPA and Change Control processes, including identification, implementation, follow-up actions, and effectiveness review.
• Review and maintain Quality Technical Agreements with suppliers, service providers, and outsourced partners.
• Maintain the training matrix, identify quality and GDP training requirements, and monitor completion of mandatory training across the team.
• Support and promote a strong quality and risk management culture across the Ukraine business.
• Identify areas for process improvement and report recommendations to the CEO.
• Escalate any suspected falsified medicines, serious quality issues, or regulatory risks to the CEO and relevant Ukrainian competent authorities in accordance with local legislation.

Our expectations:

• Filing and record keeping ensuring good documentation practices are complied with at all times.
• Working with Quality Director and RP to ensure that all aspects of the WDA are complied with and complete all reports and logs as required.
• Report all concerns to the Quality Director and RP.
• Provide leadership and example in promoting the Company Quality Management System.
• Identify training gaps, annual training requirements and Provide Training to staff as required.
• FMD and Serialization awareness.
• Knowledge of EU/UK Clinical Trial legislations and regulations.
• Support vendor management as required to meet business needs.

Personal Attributes:

• English Upper-Intermediate.
• Act with integrity at all times.
• Able to communicate effectively
• Team Player
• 2-5 Years experience in the a GDP environment
• Pharmaceutical Experience

We are pleased to offer you:

• A hybrid role (office-based and remote).
• The opportunity to become part of a strong international team;
• Opportunities for professional growth, personal development and the delivery of large-scale international projects focused on saving lives;
• A young and friendly team with a European outlook, and a supportive environment for development;
• Competitive salary;
• A European culture of business tolerance, intelligence, friendliness, mutual support, the ability to listen, constructive and respectful feedback, and a high level of interpersonal skills;
• Paid leave, holidays and other benefits.
• If you are interested in this vacancy, please send your CV, stating your expected salary.  

We will respond within 7 days.