Head of Quality

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 Savana

Major 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 Party’s 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 :

We offer :

Details from this job description are not to be used for marketing purposes. Savana does not accept unsolicited resumes from search firms. All resumes submitted by search firms to any employee at Savana via e-mail, the Internet or directly without a valid written search agreement will be deemed the sole property of Savana, and no fee will be paid in the event the candidate is hired by Savana.

Medsavana S.L. (“Medsavana”) will process the personal data you provide to us during the selection process (the “Candidate’s Personal Data”) in order to manage your curriculum data and the selection process you are applying to. You can exercise the rights of access, rectification or erasure, restriction of processing, objection, portability, and to object automated individual decisions at the registered office of the company indicated or in the email [email protected]. For more information, please refer to the privacy policy section on our webpage : https : / / www.savanamed.com / es / curriculum /