Compliance Manager
17 days ago
Barcelona
Company Description ¿Está considerando presentar su candidatura para este trabajo? Compruebe todos los detalles en esta descripción del puesto y luego haga clic en "Solicitar". IOMED operates an AI-powered Data Space Platform designed to mediate and enable the secondary use of health data while ensuring compliance with data protection standards. By leveraging advanced technologies such as Natural Language Processing, IOMED processes both structured and unstructured clinical data, transforming it into the OMOP Common Data Model for standardized analysis. Using a Federated Data Model, all data remains within hospitals' in-house systems to uphold security and privacy. With a mission to advance data-driven healthcare, IOMED serves as a key ally to healthcare organizations, accelerating their transitions toward innovative solutions. As a Compliance Manager you will be working in a very dynamic environment, which means that you must have a strong problem-solving ability, organization skills, and be proactive. You are excited by the prospect of rolling up your sleeves to tackle meaningful problems every day. Main Responsibilities You will lead our Quality and Information Security Management System across IOMED’s software, research products and services. You will be responsible for strengthening, further developing and executing the quality assurance program and management systems. You will: • In partnership with other team leaders, define and drive the strategy to continuously improve the QMS and ISMS to support adherence to the applicable requirements and enhance the system utilizing a risk-based, fit-for-purpose approach., • Coordinate teams, and develop programs that support the management infrastructure including document and training management; audit/inspections programs; CAPA management; metrics; and QA support to project teams/programs., • Develop and oversee the Quality and Information Security Management System and key metrics of activities (e.g. document management, vendor compliance management, CAPAs, internal audits, etc.) to ensure it continuously meets requirements. Develop reporting tools and metrics for communication to senior leadership., • Develop and lead implementation of risk-based fit-for purpose Quality Assurance (QA) activities focused on risk assessment; issue identification, escalation, management; and corrective/preventive action (CAPA) management, and continuous improvement., • Serve as a senior quality consultant/advisor to teams and leadership providing quality advice regarding topics such as: interpretation of applicable requirements; research best practices; document management; process development/improvement; audit and inspection readiness; and risk management., • Lead external audit/regulatory authority inspection program, including liaising with clients, hosting on-site visits, and internal facilitation/oversight of associated action plans., • Lead the relationship with our DPO to ensure that IOMED meets its legal obligations regarding data protection and people's privacy., • Develop and oversee the internal audit program focused on identifying gaps, risks and opportunity for improvement., • A Bachelor's Degree (preferred in a relevant area, e.g., healthcare, quality, information security or pharmacovigilance)., • Strong project management, organizational, and analytical skills., • Good x Practice (GxP) subject matter expertise, preferably in Clinical or Pharmacoepidemiology., • Direct experience planning, conducting, and supporting internal audits, external audits, and health authority inspections. Experience in having already led ISO 9001, ISO 27001 and/or ISO 27701 will be extremely valued., • Strong experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs)., • Excellent verbal and written communication skills with demonstrated success working cross-functionally., • A problem solving mindset and demonstrated ability to deliver results; ability to distill complex issues and translate them into concrete action plans., • Comfortable working with remote teams and operating in a fast-paced, growing technology environment., • Experience with or an understanding of scientific methodologies or statistics., • Experience with clinical research, especially in oncology or clinical trials network setting., • Experience in epidemiological or outcomes research (real-world evidence), • Competitive salary., • Permanent contract., • Flexible remuneration with restaurant tickets, transport tickets, nursery, training, and medical insurance (if based in Spain)., • Flexible schedule and hybrid/remote working model., • 28 days of vacations per year. xcskxlj, • A warm, transparent and supportive team, with a huge emphasis on work-life balance.