Director, Quality And Regulatory

hace 6 días


Barcelona, España Mygwork A tiempo completo

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.#J-18808-Ljbffr



  • Barcelona, España Mygwork A tiempo completo

    .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...


  • Barcelona, España Mygwork A tiempo completo

    .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...


  • Barcelona, España Thermo Fisher Scientific A tiempo completo

    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...


  • Barcelona, España Mygwork A tiempo completo

    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...


  • Barcelona, España Mygwork A tiempo completo

    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...


  • 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'...


  • Barcelona, Barcelona, España Werfenlife Sa. A tiempo completo

    Quality and Regulatory Affairs (QA/RA) TraineeThe Quality and Regulatory Affairs (QA/RA) Trainee supports the execution of preand/or post market regulatory affairs departmental functions, including, but not limited to,assisting in the preparation of documentation and information required to place and tokeep products on the market: regulatory submissions,...


  • Barcelona, España Ipsen Pharma SA A tiempo completo

    At 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...


  • Barcelona, España AstraZeneca A tiempo completo

    At **AstraZeneca **we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth...


  • Barcelona, Barcelona, España Ipsen Pharma SA A tiempo completo

    At 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 the relationship and...


  • Barcelona, Barcelona, España Werfen A tiempo completo

    Overview Post Date November 7, Number WEBWW-- Job Function QA&RA Location Barcelona, Spain Country Spain About the Position ob Summary The Quality and Regulatory Affairs (QA/RA) Trainee supports the execution of pre and/or post market regulatory affairs departmental functions, including, but not limited to, assisting in the preparation of...


  • Barcelona, España Recruiting Erasmus A tiempo completo

    **AstraZeneca** is an innovation-driven global biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines, primarily for the treatment of cardiovascular, renal, and metabolic, respiratory, and immunological, oncological and rare diseases. In line with our firm commitment to training and developing...


  • Barcelona, Barcelona, España Recruiting Erasmus A tiempo completo

    AstraZeneca is an innovation-driven global biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines, primarily for the treatment of cardiovascular, renal, and metabolic, respiratory, and immunological, oncological and rare diseases.In line with our firm commitment to training and developing exceptional...


  • Barcelona, Barcelona, España AstraZeneca A tiempo completo

    At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and...


  • Barcelona, España Iqvia A tiempo completo

    The Associate Director – Regulatory Submissions The Associate Director – Regulatory Submissions is responsible to lead a worldwide Regulatory Submissions delivery team within IQVIA Translations. This team is in charge of the development and harmonization of the Regulatory Submissions Process. The Associate Director – Regulatory Submissions has...


  • Barcelona, España Consult Search A tiempo completo

    **Scope**: Director of regulatory affairs position that has been opened to further accompany the growth of the company on this sector. Although our client is a historically pharma oriented manufacturer, they have in the recent years expanded their activities in the Medical Aesthetics area, with products currently on market in the Dermal and Hyaluronic acid...


  • Barcelona, España Astrazeneca A tiempo completo

    .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 provides expert communications leadership to drug projects and authors strategically important...


  • Barcelona, España AstraZeneca A tiempo completo

    Role holders expertly drive strategic communications excellence to achieve successful submissions and approvals. They develop innovative best practices and improvement initiatives. **Typical Accountabilities** The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important...


  • Barcelona, España AstraZeneca A tiempo completo

    Role holders provide strategic leadership and communications expertise to clinical drug programs. They author clinical-regulatory documents and provide critical review to achieve high quality standards. They represent the skill on drug and non-drug projects. **Typical Accountabilities** The Clinical Regulatory Writing team provides expert communications...


  • Barcelona, España Werfenlife Sa. A tiempo completo

    Quality and Regulatory Affairs (QA/RA) TraineeThe Quality and Regulatory Affairs (QA/RA) Trainee supports the execution of preand/or post market regulatory affairs departmental functions, including, but not limited to,assisting in the preparation of documentation and information required to place and tokeep products on the market: regulatory submissions,...