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Regulatory compliance and deputy qualified person (madrid) (y-518)

Madrid
Merck
Publicada el 22 septiembre
Descripción

Overview
Job Location: Tres Cantos, Madrid, Spain
Job Type: Full-time
Aplica tu Magia con nosotros
Estás listo para explorar, romper barreras y descubrir mucho más?
Sabemos que tienes grandes planes.
Nosotros, también, innovar con la ciencia y la tecnología para enriquecer la vida de las personas con las soluciones en Healthcare, Life Science y Electronics apasiona a nuestros colegas en el mundo entero.
Juntos, soñamos en grande y compartimos el entusiasmo por cuidar a una gran diversidad de personas, clientes, pacientes y al planeta.
Por eso, siempre buscamos mentes curiosas que imaginen lo nunca visto con nosotros.
Unidos como uno solo para los pacientes: nuestra meta en Healthcare es ayudar a crear, mejorar y prolongar vidas.
Creamos tratamientos, dispositivos inteligentes y tecnologías innovadoras en campos terapéuticos como la oncología, la neurología y la fertilidad.
Nuestros equipos colaboran en 6 continentes con pasión y una curiosidad incesante con el objetivo de ayudar a los pacientes en cada etapa de su vida.
Unirte a nuestro equipo de Healthcare significa formar parte de una cultura de trabajo diversa, inclusiva y flexible, que ofrece fantásticas oportunidades para el desarrollo personal y profesional en todo el planeta.
Your Role
Your Role :As Deputy Qualified Person and Site Regulatory expert of manufacturing site in Madrid (Tres Cantos), you will assure that products are manufactured and tested in compliance with GMP requirements and Marketing Authorizations.
You will play a pivotal role in coordinating projects, submission strategies and implementation of changes considering scientific and technical progress.
Who You Are
You hold a university degree in pharmacy.
You bring at least 5 years of experience as Qualified Person and/or Regulatory Affairs field.
You have a deep understanding of GMP (Good Manufacturing Practices) and quality systems within pharmaceutical manufacturing.
Your knowledge of applicable EU and highly regulated countries regulations is current and comprehensive.
You are comfortable taking legal responsibility for batch release in compliance with EU directives and applicable quality standards.
Your strong stakeholder management and communication skills enable you to navigate complex environments effectively.
You excel at time management, gaining alignment, and executing strategic activities successfully.
You prioritize competing tasks effectively in a fast-paced, dynamic environment.
You have a strong ability to resolve conflicts constructively and maintain a solution-oriented mindset.
You are a proactive driver of change—someone who takes initiative and ensures things get done.
You are fluent in both Spanish and advanced skills in standard MS Office and SAP system.
Lo que ofrecemos
Somos mentes curiosas que provienen de una amplia gama de antecedentes, perspectivas y experiencias de vida.
Creemos que esta variedad impulsa la excelencia y la innovación, fortaleciendo nuestra capacidad para liderar en ciencia y tecnología.
Estamos comprometidos a crear acceso y oportunidades para que todos se desarrollen y crezcan a su propio ritmo.
Únete a nosotros para construir una cultura de inclusión y pertenencia que impacte a millones y empodere a todos para defender el progreso humano.
Aplica ahora y conviértete en parte de un equipo que se dedica a Despertar el Descubrimiento y Elevar a la Humanidad
US Equal Employment Opportunities
The Company is an Equal Employment Opportunity employer.
No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.
This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.
Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately.
The Company will not retaliate against any individual because they made a good faith report of discrimination.
Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities.
If you think a fraudulent source is offering you a job, please have a look at the following information here.
Applicant Profile
Along with our brand-new career site, we\'ve also revamped our application process.
If you\'ve applied for a position before April 16th 2025, you can log into your old profile to see the status of past applications.
For the application you\'ve completed, and any in the future, you can create a new profile to check in on your status.
WHAT WE OFFER
Money makes the world go round.
But at our company there\'s more than just financial rewards.
We offer a range of attractive benefits to help you work your magic.
Saving & Financial
Our 401(k) Plan includes a generous company-matching contribution and an additional discretionary contribution each year.
We also provide tax-advantaged accounts for you to save for healthcare, commuting expenses, company-provided and buy-up life insurance to help you protect your financial future.
Health & Wellness
We offer comprehensive medical, dental, & vision coverage—including virtual care through Telehealth & free behavioral health counseling sessions through our Employee Assistance Program.
We also offer a wellness incentive program and personalized support to help you navigate and use your benefits.
Voluntary Benefits
Our voluntary benefits provide additional protection from the high costs of healthcare not covered by health insurance.
We also have discount programs that offer exclusive savings on everything from auto, home, and pet insurance to low-interest personal loans.
Work / Life Support
We have several programs to support your work / life balance, including generous paid time off, back-up day care services, education assistance, and more.
OUR RECRUITING PROCESS
Depending on the position (level, functional area, country) the process can vary slightly.
You applyComplete your online application for your preferred role(s) that match your interests and qualification.
If you cannot find a suitable role please join our Talent Zone and stay connected for your next career opportunity.
We screenWe review your application and if we determine that you are a good fit we will move you to the selection process.
We assessYou are interviewed by phone, via video and / or face to face.
Mutual agreementIdeally you are the perfect match for us We hope you consider us as your new employer.
Work your magic
To guarantee you a smooth start our onboarding preparation begins.
Haven't found the right job yet?
Join our Talent Community to stay connected and explore future opportunities.
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