Johnson & Johnson Careers

Quality Head CZ

Prague, Czech Republic
Quality (Generalist)


Job Description

Requisition ID: 1905771697W

The Johnson&Johnson Family of Companies makes a big difference in the health and well-being of people every day. We have more than 250 operating companies in 57 countries employing approximately 114,000 people. Our consumer products and medical devices and diagnostics impact the state of health care for patients, doctors, and nurses around the world. Currently for Janssen, we are looking for highly motivated candidate for the position of:

 
Quality Head CZ
Location: Prague
Contract: Unlimited
 

This position serves as a local leader of quality and compliance and oversees the quality status of all regulated functions in an LOC. The Quality Head is responsible for the implementation and maintenance of a Quality Management System (QMS) for regulated activities in an LOC (pre- and post-marketing) and ensures, in collaboration with the various LOC/Cluster leads of the regulated functions (e.g., Local Safety Officers (PV), Head of Regulatory, etc.), that the implementation meets the requirements of J&J Quality Policy POL-001 and that all applicable global, regional and local regulations are met in the LOC. 


Main tasks:

  • To define and implement the local / cluster quality strategy in line with regional BQ strategy and local business strategy.
  • To lead and co-ordinate the development and deployment of an effective LOC QMS
  • Responsible to obtain and maintain the required QMS compliance certificates, licenses and quality agreements for the LOC
  • To be the LOC lead for quality oversight and risk management
  • To be the LOC point of contact for quality
  • Manage the local BQ organisation and resources
  • Manage the GMP/GDP and product quality aspects
  • Implement, maintain and monitor the GMP/GDP part of the J&J quality system for commercial organisations in the LOC/ Manage local processes
 


Qualifications

Crucial requirements for candidates:

 
  • Primary degree in Chemistry / Pharmacy / Microbiology / Medicine or a related scientific discipline;
  • At least 3 (ideally 5) years’ experience in the Pharmaceutical industry, Quality Management System experience is essential;
  • Understanding of pharmaceutical product development, release and distribution processes;
  • Up-to-date knowledge of relevant pharmaceutical legislation and GMP/GDP;
  • Strong self-reliable, analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners;
  • Knowledge and full understanding of the J&J Quality Policy and Standards, the Cluster / LOC QMS and CLS QMS
  • Business acumen to balance safety, compliance and availability of product for a patient
  • Team player within region, ability to leverage across LOC’s in EMEA / WW
  • Open for standardization: regional and local thinking, team player at EMEA level

In return, we offer:

  • An opportunity to be part of a global market leader.
  • A dynamic and inspiring working environment.
  • Many opportunities to work on challenging projects and assignments.
  • Possibilities for further personal as well as professional development.


Primary Location
Czech Republic-Prague-Prague-
Organization
Janssen-Cilag .s.r.o (8397)
Job Function
Quality (Generalist)
Requisition ID
1905771697W