Quality Manager

Company DescriptionBiologit is an innovator in pharmacovigilance (PV), revolutionising the way life science organisations handle literature review and monitoring, using cutting-edge automation technology. Founded with a mission to enhance patient safety and operational efficiency, Biologit empowers pharmaceutical, biotech and PV service providers to simplify and streamline their processes. At the heart of Biologit’s Platform is its AI-powered literature automation tool, designed to transform manual and time-intensive tasks into seamless, efficient workflows. Biologit adheres to the highest industry standards, including ISO 27001 certification, GxP compliance, EU AI Act, GDPR and alignment with FDA and EU regulations.Role DescriptionThis is a full-time remote role in Ireland for a Quality Manager at Biologit. The Quality Manager will play a critical role in ensuring operations adhere to stringent regulatory requirements (GxP, CFR 11, GDPR and EU AI Act). You will be responsible for developing, managing and overseeing compliance activities, conducting audits, maintaining and reviewing vendor qualifications and assessments and providing guidance to cross-functional teams.Key Responsibilities:Develop, implement, and maintain compliance programs to ensure adherence to GxP, 21 CFR Part 11, and the EU AI Act.Oversee the validation and qualification of computerised systems (including AI enabled software) used for GxP activities, ensuring full compliance with relevant regulatory standards (e.g., FDA 21 CFR Part 11, EU Annex 11).Manage change management and coordinate risk assessments and impact analyses for new systems, ensuring their suitability for regulated use.Conduct regular audits and assessments of internal processes and systems to ensure compliance with regulatory requirements.Investigate and resolve compliance issues, and implement corrective and preventive actions.Provide support and develop vendor management and assessment.Develop and maintain vendor contracts that include compliance requirements, ensuring proper documentation and communication channels.Collaborate with clients to ensure smooth onboarding processes and align their needs with internal compliance protocols.Serve as point of contact for compliance-related issues with clients, addressing their concerns and ensuring their projects comply with all regulations.Collaborate with cross-functional teams to ensure compliance in all areas of the business, including engineering, product development, pharmacovigilance, operations and quality assurance.Provide guidance and training to staff on compliance-related matters, including GxP, GDPR, EU AI Act and computer systems validation.Monitor and interpret changes in relevant regulations and standards, and update company policies and procedures accordingly and foster continuous improvements.Competencies:Excellent organisational abilities, personal efficiency, and time management, with a strong capacity to prioritise competing demands.Skilled in building relationships and fostering collaboration with others.Effective in strategic decision-making, serving as an influential voice within the business.Proven ability to prioritise critical initiatives, drive business growth, and establish KPIs for performance monitoring.Positive, proactive, and motivated by taking on significant responsibilities.Practical and action-oriented approach to managing teams and priorities.Proficient in software for QMS, LMS, MS Office and AI enabled tools.Requirements:Bachelor’s degree in a Science related discipline.Desirable a minimum of 5 years experiences of working in a similar role in the pharmaceutical industry.Knowledge of quality related pharmaceutical regulations, including ISO.What We Offer:Competitive salary and benefits.Opportunity for growth and development.Flexible working conditions.