External Manufacturing Regulatory Compliance Manager f/m

Posted 20 Jan 2023

Lyon, Rhone - France

Req Id 260187

 

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

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:

 

Part of the Global External Supply Quality organization (ESQ), External Manufacturing Regulatory Compliance (EMRC) is a global function supporting external manufacturing of our medicinal products worldwide in compliance to local Product Marketing Authorization, specifically to the CMC (Chemistry, Manufacturing and Control) or equivalent part of the dossier.

The position of EMRC manager is at the interface between our Global organization and Local Regulatory Affairs and the External Manufacturers or the function managing External Manufacturing Quality.

You are accountable for a portfolio of External Manufacturers (CMOs) mainly located in Europe and related Drug Products supplied worldwide. You build and maintain Regulatory Compliance Files (= abbreviated version of dossier registration covering the manufacturing and testing of the products) and provide them to the External Manufacturers. You assess the reportability (impact on the dossier registration) of External Manufacturers change requests.

You participate to Products Compliance checks through verification of External Manufacturers master documentation or participation to External Manufacturers audits.

You support remediation to potential compliance gaps e.g. during Product Compliance Alerts or CAPAs.

 

Possible locations Lyon (France), Darmstadt (Germany) or Aubonne (Switzerland)

 

Who you are:

 

  • BS in Pharmaceutical Science or equivalent.
  • You demonstrate 5+ years of experience in the pharmaceutical / biopharmaceutical, medical, or life sciences.
  • Familiar with EU Good Manufacturing Practices, and other main GMP standards (WHO, …)
  • You have broad insight of pharmaceutical manufacturing, quality control and drug product dossier registration (understanding CMC dossier structure and content).
  • You are experienced in working with external partners (e.g., contract manufacturing organizations, contract laboratories and suppliers), in quality and/or compliance role.
  • You are comfortable working with cross-functional and multi-cultural teams in a fast paced and dynamic environment, and able to influence others regarding compliance concerns.
  • You are well organized and detailed oriented.
  • You have excellent verbal and written communication in English.
  • You are interested to evolve in role combining External Manufacturing Quality and Regulatory Compliance.


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!


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: https://www.emdgroup.com/en/careers/faqs.html

Apply Now

Let’s stay connected

You want to check the status of your application or change your candidate profile? Enter our job portal to access your candidate profile.