Director, Quality And Regulatory
hace 5 meses
Thermo Fisher Scientific - Barcelona, Spain Details Negotiable Full-Time 1 position When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.Position Summary:The Director, Quality and Regulatory will oversee the High-Performance Chromatography Solutions (HPCS) and Software Business Unit quality system and quality assurance strategies. Reporting to the Vice President of Chromatography & Mass Spectrometry Division (CMD) QARA, this position will be responsible for ensuring the highest level of quality and compliance in our operations, products, and services. Your expertise and leadership will be instrumental in driving continuous improvement, implementing quality management systems, and ensuring regulatory compliance in a rapidly evolving industry. This role will provide leadership by ensuring strategic quality planning, regulation monitoring, and QMS integration/improvement activities are effectively established and maintained according to business needs.Key Responsibilities:Build and drive a Quality vision and strategic objectives that aligns with our High-Performance Chromatography Solutions BU.Lead and inspire a strong global quality team by hiring and developing strong quality leaders, establishing and actively managing performance expectations, and providing development and training opportunities.Drive operational excellence by effectively using continuous improvement skills and tools to prioritize and drive projects and improvements/standardization across the network to improve Product Quality, reduce costs of poor quality, and align with strategic objectives.Establish network wide QA priorities and key objectives to improve the compliance to regulations and the global Quality Management System.Ensure global QMS training is effective and operate within the required regulatory guidelines.Uphold awareness of applicable standards and regulations, and monitor activities related to change to the standards and regulationAssess product regulations and standards and the impact to meet global requirementCollaborate with corporate & divisional partners regarding quality issues, audits, and special projectsInfluence and build strong working relationships across organizations and geographies and engage with business partners to define existing gaps and future requirements for Quality Management Systems.Ensure effective management of the global Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, internal auditing, NPDI.Drive the continuous improvement of Quality Management Systems, including assuring effective management reviews, complaint handling, CAPA system, change control, internal auditing, and NPDI process support.Support the commercialization of New Product Introductions by working with cross functional NPDI team members.Collaborate with Regulatory organization to ensure compliance to applicable regulations.Lead executive quality management reviews.Other miscellaneous duties as assigned.Minimum Requirements/Qualifications:Bachelor's degree in a relevant scientific or engineering field; advanced degree preferred.Extensive experience (at least 5-10 years) in quality management preferably within the Life Sciences, Pharmaceutical Industry or software industry.Customer focus - Puts the customer at the front of every decision, including work prioritization, resource investment, and process improvementQuality systems - Ability to practically implement strong quality systems that provide the necessary controls as defined by regulatory, marketplace and our customers.Building a team - Builds a strong team and has a strong capability to marry strategy, organizational structure, and capable leadersOperational execution - Clear view of the mechanisms necessary to manage a quality assurance organization efficiently and effectivelyAbility to demonstrate flexibility and manage multiple complex projects simultaneouslyAbility to manage from and across remote locationsAbility to travel up to 30%At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and saferThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Director, Quality and Regulatory
hace 3 meses
Barcelona, España Thermo Fisher Scientific A tiempo completo**Work Schedule** Other **Environmental Conditions** Office We are currently seeking a highly motivated and experienced Director, Quality and Regulatory to join our Engineering team at Thermo Fisher Scientific Inc. As a world-class leader in the industry, Thermo Fisher Scientific Inc. provides exceptional opportunities for growth and...
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Director, Quality And Regulatory
hace 1 mes
Barcelona, España Thermo Fisher Scientific A tiempo completo. Thermo Fisher Scientific - Barcelona, Spain Details Negotiable Full-Time 1 position When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving...
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Director, Quality And Regulatory
hace 1 mes
Barcelona, España Thermo Fisher Scientific A tiempo completo.Thermo Fisher Scientific - Barcelona, Spain Details Negotiable Full-Time 1 position When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving...
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Director, Quality And Regulatory
hace 1 semana
Barcelona, España Thermo Fisher Scientific A tiempo completo.Thermo Fisher Scientific - Barcelona, SpainNegotiableFull-Time1 positionWhen you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career...
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Director, Quality and Regulatory
hace 6 meses
Barcelona, España Thermo Fisher Scientific A tiempo completoWhen you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. **Position Summary**: The Director, Quality and Regulatory...
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Director, Quality and Regulatory
hace 2 semanas
Barcelona, España Thermo Fisher Scientific A tiempo completoThermo Fisher Scientific - Barcelona, SpainNegotiableFull-Time1 positionWhen you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your...
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Director, Quality and Regulatory
hace 2 semanas
Barcelona, España Thermo Fisher Scientific A tiempo completoThermo Fisher Scientific - Barcelona, SpainNegotiableFull-Time1 positionWhen you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your...
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Director, Quality and Regulatory
hace 2 semanas
Barcelona, España Thermo Fisher Scientific A tiempo completoThermo Fisher Scientific - Barcelona, Spain Negotiable Full-Time 1 position When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your...
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Director, Quality And Regulatory
hace 2 semanas
Barcelona, España Thermo Fisher Scientific A tiempo completoThermo Fisher Scientific - Barcelona, SpainNegotiableFull-Time1 positionWhen you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career...
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Director of Quality and Regulatory Affairs
hace 1 mes
Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completoJob Title: Director, Quality and RegulatoryAt Thermo Fisher Scientific, we have an exciting opportunity for a Director, Quality and Regulatory to join our High-Performance Chromatography Solutions Business Unit. This role will be responsible for overseeing the quality system and quality assurance strategies, ensuring the highest level of quality and...
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Regulatory Affairs Senior Director of Quality
hace 3 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob Description: As a Regulatory Affairs Senior Director of Quality, you will lead and manage a team of regulatory professionals within the Regulatory API (RAPI) department, driving the delivery of high-quality documentation to support successful submissions to regulatory authorities. Your key responsibilities include:
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Senior Quality and Regulatory Specialist
hace 3 semanas
Barcelona, Barcelona, España Babel Profiles S.L A tiempo completoWe are seeking a seasoned Senior Quality and Regulatory Specialist to join our team in Barcelona.This role will focus on leading the entire quality and regulation area, ensuring that products meet the highest standards and regulatory requirements.The ideal candidate will have extensive experience in manufacturing, with a strong background in ISO 9001 and...
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Director of Regulatory Development and Strategy
hace 6 meses
Barcelona, España Ortolan Group A tiempo completo**Director of Regulatory Development and Strategy** **UK or EU based (Hybrid working with some travel)** **Salary**: Competitive + Benefits + Bonus If you are a dynamic regulatory leader with expert technical and tactical experience in regulatory strategy in the UK, EU and internationally then we want to hear from you. Join us to help improve peoples'...
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Global Quality Regulatory Api Specialist
hace 2 meses
Barcelona, España Insud Pharma A tiempo completoWho we are?Today, we are a pharmaceutical group with a track record spanning over 45 years and a footprint in more than 50 countries, led by Leandro and Lucas Sigman.Our overarching goal is to improve people's health all over the world, providing accessible, effective, safe, quality medicines through our various business units, underpinned by continuous...
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Global Quality Regulatory Api Specialist
hace 2 semanas
Barcelona, España Insud Pharma A tiempo completoWho we are?Today, we are a pharmaceutical group with a track record spanning over 45 years and a footprint in more than 50 countries, led by Leandro and Lucas Sigman.Our overarching goal is to improve people's health all over the world, providing accessible, effective, safe, quality medicines through our various business units, underpinned by continuous...
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Medical and Regulatory Affairs Director Iberia
hace 6 meses
Barcelona, España Ipsen Pharma SA A tiempo completoAt Ipsen, we are looking for a **Medical and Regulatory Affairs Director Iberia **based in** Barcelona**. Following the general strategies of the company and the department guidelines, as well as all the procedures and policies, current legislation, code of conduct, and deontology. Your main responsibilities will be: - ** Medical Director** - To promote...
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Quality and Assurance Manager
hace 3 semanas
Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completoJob DescriptionWe are seeking an experienced Director, Quality and Regulatory to lead our Engineering team at Thermo Fisher Scientific Inc.Responsibilities:Develop and implement quality and regulatory strategies to drive continuous improvement.Collaborate with cross-functional teams to ensure flawless execution of quality and regulatory initiatives.Oversee...
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Director, Clinical Regulatory Writing
hace 4 semanas
Barcelona, España Astrazeneca A tiempo completo.Location: Barcelona, Spain (on-site) - 3 days working from the office and 2 days working from home.Job DescriptionRole holders expertly drive strategic communications excellence to achieve successful submissions and approvals. They develop innovative best practices and improvement initiatives.Typical AccountabilitiesThe Clinical Regulatory Writing team...
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Regulatory Affairs Associate Director
hace 2 meses
Barcelona, España Sandoz A tiempo completo.As Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project planes. Including preparation of registration documentation and assessment of appropriateness of registration documentation...
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Director, Clinical Regulatory Writing
hace 4 semanas
Barcelona, España Astrazeneca A tiempo completo.Location: Barcelona, Spain (on-site) - 3 days working from the office and 2 days working from home.Job DescriptionRole holders expertly drive strategic communications excellence to achieve successful submissions and approvals. They develop innovative best practices and improvement initiatives.Typical AccountabilitiesThe Clinical Regulatory Writing team...
