QAra Director Biotechnology
hace 3 semanas
Our client is a start-up that develops accelerated solutions for the diagnosis of bacterial infections.
As part of its rapid growth and the industrialisation of its products, the company is looking for a QARA Director. You will be responsible of the implementation of company’ s QMS covering all steps of a product life, from design to manufacturing and post marketing.
**Your mission**:
As QARA Director you will be responsible for:
- Leading the regulatory approval in both Europe and USA
- Managing of a team with employees, international partners and consultants involved in the project
- Deploying and maintaining a Quality System compliant with EU (ISO 13485) and USA (cGMP, 21 CFR 820) Design Controls and product development cycle regulations
- Bringing innovative ideas and processes to implement a QMS for a world-class instrument for direct blood pathogen detection and antibiotic susceptibility testing
- Ensuring the process validation of each manufacturing steps, especially for the industrialisation stage
- Passing notified bodies regulatory audits
**Your profile**:
- Solid IVD experience (10 years, preferentially in a leading position for an analytical system QMS development)
- Expertise in leading all documentation efforts needed for regulatory agencies
- Successful track record of deploying and maintaining a Quality System in EU and the USA
- Obtaining at least one European regulatory approval for an IVD system.
- Used to the importance of sterility and contamination control.
- Proven track record of passing notified bodies regulatory audits.
- Experience obtaining Regulatory approvals of molecular diagnostics (PCR) and / or AST (Antimicrobial Susceptibility Testing)
- Leadership and able to build constructive discussions with other company division (Reagents, medical affairs, engineering, and operations)
- Management experience in leading internal teams and external partners (industrial and consultants)
If you want to join a fast-growing start-up developing an innovative IVD solution and that you're living or willing to relocate to Barcelona, contact us
**Job Types**: Full-time, Permanent
**Salary**: 100,000.00€ - 150,000.00€ per year
Work Location: In person
-
QAra Director Biotechnology
hace 1 mes
Barcelona, España Axeme Conseil A tiempo completoOur client is a start-up that develops accelerated solutions for the diagnosis of bacterial infections. As part of its rapid growth and the industrialization of its products, the company is looking for a QARA Director. You will be responsible of the implementation of company’ s QMS covering all steps of a product life, from design to manufacturing and...
-
QARA Manager
hace 2 semanas
Barcelona, España Page Personnel A tiempo completo¿Dónde vas a trabajar? Leader Pharma Company. ¿Qué harás en tu nuevo puesto? Cooperating with the QA/RA Director to co-ordinate quality assurance activites.Mantaining Quality Management system procedures.Cooperating with different company departments for implementing quality system procedures.Supporting internal and external Quality System...
-
Evidence Delivery Associate Director
hace 4 semanas
Barcelona, España TFS HealthScience A tiempo completoTFS HealthScience is excited to be expanding our **SRS **team and we are looking for an experienced, highly motivated **Evidence Delivery Associate Director** who shares our vision of providing clinical research excellence. Our **SRS** team is a highly experienced international group of professionals led by an industry expert. We are a leading global...
-
Evidence Delivery Director
hace 4 semanas
Barcelona, España TFS HealthScience A tiempo completoTFS HealthScience is excited to be expanding our **SRS **team and we are looking for an experienced, highly motivated **Evidence Delivery Director** who shares our vision of providing clinical research excellence. Our **SRS** team is a highly experienced international group of professionals led by an industry expert. We are a leading global mid-size...
-
Gene Therapies Scientist
hace 4 semanas
Barcelona, España Kymos A tiempo completoWe are looking for a scientist for a Gene therapies project that is being developed in our department of innovation under supervision of the Director of Innovation. Examples of the assays to be developed are: aggregation, empty capsid vs intact viral particles, charge heterogeneity, transgene expression, characterization of the viral proteins, potency,...
-
Launch Medical Director
hace 4 semanas
Barcelona, España Novartis A tiempo completoBringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology. As a global company, the resources and opportunities for growth and development are plentiful including global and local cross functional careers, a diverse learning suite of thousands of programs & an...
-
Associate Director, Global Program Manager
hace 1 día
Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completoLocation: Barcelona, Spain Job reference: R-198241 Date posted: 04/26/2024 **This is what you will do**: The Associate Director, Global Program Manager (GPM) is responsible for co-leading the strategic and operational planning and decision-making processes with an Alexion Global Program Team (GPT). Working in partnership with the Global Program Team...
-
Director, R&d Global Program Manager
hace 4 días
Barcelona, España AstraZeneca A tiempo completo**This is what you will do**: The Director, Global Program Manager (GPM) is responsible for co-leading the strategic and operational planning and decision-making processes with an Alexion Global Program Team (GPT). Working in partnership with the Global Program Team Leader (GPTL), the GPM provides strategic vision and guidance to the team by developing...
-
QA/RA Manager
hace 1 mes
Barcelona, España Page Personnel A tiempo completoQARA Manager.|Pharma Company (Vallés Or.).Leader Pharma Company.Cooperating with the QA/RA Director to co-ordinate quality assurance activites.Mantaining Quality Management system procedures.Cooperating with different company departments for implementing quality system procedures.Supporting internal and external Quality System audits.Supervising software...
-
Associate Director, Global Program Manager
hace 6 días
Barcelona, España Astrazeneca Gmbh A tiempo completoThis is what you will do: The Associate Director, Global Program Manager (GPM) is responsible for co-leading the strategic and operational planning and decision-making processes with an Alexion Global Program Team (GPT). Working in partnership with the Global Program Team Leader (GPTL), the GPM provides strategic vision and guidance to the team by developing...
-
Director, Research
hace 3 días
Barcelona, España Splice Bio A tiempo completoAs SpliceBio is growing, we're looking for exceptional professionals to be part of our team, supporting the development of gene therapies for diseases for which currently no treatment exists. We are now seeking an exceptional professional to join our team as the Director, Research & Innovation, reporting directly to the Chief Technology Officer. In this...
-
Sr HR Director EMEA
hace 3 semanas
Barcelona, España Cepheid A tiempo completoAt Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and...
-
Auditor in the Quality Assurance Unit
hace 1 mes
Barcelona, España Anapharm Bioanalytics A tiempo completoMAIN DUTIES & RESPONSIBILITIES Conduct internal audits (both study specific and Quality System related) and coordinate inspections by external auditors, according to GCP and GLP regulations. Manage and execute corrective and preventive actions (CAPA). Prepare and organize documentation of Quality System (SOPs, forms, training records, etc.). ...
-
Barcelona, España AstraZeneca A tiempo completo**About AstraZeneca** At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of...
-
Back Office Representative
hace 3 semanas
Barcelona, España Werfenlife Sa. A tiempo completoBack Office Representative (German Language)The Back Office Representative is responsible for efficient day-to-day order management, including receiving customer orders from Customers in Europe, cleansing orders, removing order blocks, processing change requests, liaise with other Supply Chain functions to managing order releases. This role works with...