Head of Quality

Savana; España; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

Join a forward-thinking company dedicated to transforming health through Artificial Intelligence. As the Head of Quality, you will lead initiatives that ensure compliance with regulatory standards while fostering a culture of excellence within a multidisciplinary team. This role offers the chance to make a significant impact in the healthcare sector, working alongside experts in various fields to enhance the quality of medical services. With a commitment to innovation and a flexible work culture, this position is perfect for those passionate about improving global health outcomes.

Servicios

Competitive Salary

Flexible Work Culture

Career Development Opportunities

Multidisciplinary Team Environment

Focus on Individuality and Growth

Formación

• 5+ years experience as a Quality Manager in CROs or Pharma.
• Expertise in ISO9001, GCPs, and regulatory compliance.
• Strong communication skills for diverse audiences.

Responsabilidades

• Manage the Quality Department and ensure compliance with standards.
• Coordinate audits and oversee quality management systems.
• Train staff on quality principles and maintain ISO certifications.

Conocimientos

Quality Management

Project Coordination

Regulatory Compliance

ISO Standards Implementation

Interpersonal Skills

Communication Skills

Problem Solving

Adaptability

Educación

Bachelor's Degree in Health/Life Sciences

Master's Degree in a Relevant Discipline

Herramientas

Office 365

Descripción del empleo

SAVANA ( 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 :

• 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.
• Bachelor’s 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, computer engineers, computational linguists, mathematicians, designers, medical Natural Language Processing expert programmers and other disciplines. We are a team of professionals with a common goal : to blend the knowledge of all of us to seek excellence in our purpose. Coming from very different disciplines, we want everyone to learn from everyone, creating a unique entity that moves towards the transformation of health through Artificial Intelligence.
• An opportunity to provoke a positive impact. We seek to improve health on the planet through technology and to help people and health institutions. Our employees and collaborators strive to provide our users with the necessary tools and support to achieve a more accessible and egalitarian global health. We care about our environment and we are willing to improve it.
• An environment to express yourself as you are and enjoy what you know. We defend individuality to form a richer and more plural "ecosystem". Be yourself and tell us what you have learned and how could we use it together to help us achieve our purpose. If you like what you do, we like to work with you.
• Competitive salary conditions, flexible culture and a development framework to growth your career. People are our main asset, so we invest in training and development and recognize and compensate for achievements and valuable work. We trust in the talent and commitment of people and focus on objectives and results, so we are flexible in our way of working, providing a framework to reconcile our personal and professional lives.

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 For more information, please refer to the privacy policy section on our webpage :