QA Systems & Compliance Manager (m/f/d)

Merck KGaA Darmstadt Germany

Visualizza: 141

Giorno di aggiornamento: 20-03-2024

Località: Aubonne Vaud VD

Categoria: Farmaceutico / Chimico / Biotech

Industria:

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Contenuto del lavoro

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role: Our site is an end-to-end biotechnology drug substance and drug products manufacturing site with a long history of successful commercial and clinical manufacturing operations. You own the continuous improvement and compliance of site quality systems in an environment of growth and innovation. As a key member of the Quality Leadership team, define, implement and supervise all central quality systems including document control, training, change control, deviations, CAPA, risk management, inspection readiness, internal auditing and many others. Through this you ensure all our operations onsite are aligned with current GMP and support the continuous improvement of the quality of our drug products. Develop a team of robust and highly passionate Quality Experts and Quality Engineers who thrive to bring the site to quality excellence. Be responsible to host regular Quality Management reviews with the Site Leadership Team and the site Quality Leadership Team to ensure quality systems are accurately staffed and appropriate preventive measures are defined when needed.

Who you are
  • MSc/PhD in a life science related field (Biology, Chemistry, Pharmacy) or other appropriate university degrees.
  • An experience of at least 8 years in leading quality/compliance teams in the biopharma or medical device industry
  • Sound knowledge of EU / US cGMP, their interpretation and their application in the industry
  • Good understanding of quality assurance and GMP for drug substance, drug products and medical device.
  • Experience in hosting health authorities GMP inspections (US FDA, Swiss medic, MHRA, ANVISA, COFEPRIS etc.)
  • Curious, eager to innovate and apply the latest technologies to continuously improve and reach excellence (e.g. Artificial Intelligence, Robotic Process Automation)



What we offer:With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

Job Requisition ID: 232230

Location: Aubonne

Career Level: D - Professional (4-9 years)

Working time model:

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by the Company. The Company uses the definition of "fully vaccinated" assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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 .

Job Segment:Neurology, Oncology, Biotech, Medical, Pharmacy, Healthcare, Science
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Scadenza: 04-05-2024

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