Requirements: English
Company: Savana
Region: Madrid , Community of Madrid
SAVANA (www.Savanamed.Com) is an award-winning, international medical company aiming to accelerate health science by putting into the hands of healthcare providers the power to unlock all of the clinical value embedded within existing Electronic Health Records (EHRs) with Artificial Intelligence and Natural Language Processing. Always ensuring maximum privacy and security.Founded in 2014, Savana is an international medical company that has developed a scientific methodology that applies Artificial Intelligence (AI) to unlock all the clinical value embedded within Electronic Health Records' free-text (EHRs). With the largest AI-enabled, multi-language, multi-center research network in the world, Savana generates customized descriptive and predictive, High-quality Deep Real World Evidence research studies. Engineered by doctors for doctors, the company is built following the highest privacy-by-design standards.Savana operantes in more than 160 hospitals, 5 languages, 15 countries and has already improved more than 6 clinical practices with more than 100 employees from 16 nationalities. It constitutes a clinical research ecosystem that aims to advance personalized and precision medicine worldwide.Head of Quality at SavanaMajor Accountabilities where this role is involved: Manage and coordinate the Quality Department.Ensure the Maintenance of Quality Management System adapted to Savana entities needs (e.G. specific quality policies business, product, industry and/or corporate oriented) aligned with applicable quality standards.Ensure that Quality team members maintain their skills to perform their duties and achieve the quality objectives.Ensure and promote the identification of quality requirements for the technological, clinical and pharmaceutical sectors. Ensure compliance with Internal Policies, Procedures and Manuals across all the entities of Savana. To supervise the quality level, the compliance of the controls and the degree of effectiveness of the measures applied.To liaise with senior management on quality matters (QSMR, metrics, risk reporting, action plans, deviations, CAPAs and audits status).Ensure alignment with relevant regulatory standards, specifically in Health/Pharma sectors (e.G. ICHs,Real Word Evidence, Real World Data, GCPs, etc.)Train, raise awareness and sensitize the organization on Quality Management System principles and policies. Training processes correct automation and monitoring. Support in Policies and Procedures drafting, reviewing and approval to obtain consistent Business Use Cases.Supervise and handle audits set up, including hosting of Auditors and follow up of Audit reports findings.Coordinate the Third Partys selection process, mainly including customers/vendors. Ensure the performance of the Internal and External Audit Plan.Perform Internal audits and handle external audits. Lead the Certification processes in which Savana entities could be involved.Ensure, coordinate with Information Security team and support from a Quality perspective in the maintenance of ISO certificates (e.G. currently ISO27001). Execute root cause analysis and CAPAs Definition and support departments on such tasks. Evaluate, assist and follow up Deviations CAPAs. Ensure compliance of the Quality Department in terms of Quality Management System principles.Level of compliance of their department in terms of Security of Information.Responsible for participating as a core member of the Security Committee and provide inputs for its correct function from a Quality perspective. Skills, Experience and Qualifications required:At least 5 years of experience working as a Quality Manager coordinating and leading projects.Previous professional experience: Highly valued to have worked in quality leading roles in CROs, Pharmaceutical companies focused in GCPs and RWD/RWE. Bachelors degree or Master's degree in a relevant discipline (Degree in Health/Life Sciences is a plus).Knowledge and experience on the implementation of quality standards (mandatory: ISO9001, GCPs, and highly valued: ISO13485, Sustainability standards and Information Security). General expertise working professionally and autonomously with Office 365. Strong knowledge/communication skills adaptability towards non expert audiences. English: professional working proficiency (C1).Excellent interpersonal, planning, and organizational skills.Strong verbal and written communication skills including the ability to cultivate internal and external relationships and work effectively cross-functionally.Pro-active and quality driven oriented.Team oriented with good interpersonal skills.Highly motivate to work in an innovative environment focused on HealthTech solutions. Strong flexible working attitude and high capacity on adaptability regarding continuous changes lead by the Innovation environment. Ability to work in a multinational, multidisciplinary and fast-growing environment.We offer:Work with a multidisciplinary team of clinicians, c