Johnson & Johnson Careers

Quality Manager CZ

Prague, Prague
Quality (Generalist)


Job Description

Requisition ID: 1805658523W

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.  Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson.  Please visit www.janssen.com for more information. Janssen, part of Johnson & Johnson Family of Companies is now looking for an experienced Quality Manager:
 
QUALITY MANAGER CZ
Region: Czech Republic
Full-time contract
 
Role Overview:
The QM is responsible for the GDP quality of, and meeting the applicable requirements for, the products and services marketed by the LOC as Qualified person for Good Distribution Practice and as Qualified person for Narcotics Handling according to relevant local legislation and additional applicable regulation. Quality Manager is also responsible for compliance with the elements of the Johnson & Johnson Quality Policy and J&J QMS that are applicable to the GDP activities the LOC undertakes. Quality Manager is responsible for the oversight of quality and compliance status of all third parties and other J&J organisations.
 
As Quality Manager, you will have the following areas of responsibility:
  • Maintain an up to date list of all relevant product sourcing, supply routes, product licences (marketing authorizations), product list, relevant authorizations, (e.g. importation, warehousing, distribution, narcotics handling, etc.), and quality agreements.
  • Execute requirements regarding lifecycle management of GDP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity.
  • Ensure the provision of appropriate training for all regulated functions with GxP responsibilities.
  • Ensure appropriate management of non-conformances/deviations and CAPA related to GxP.
  •  Manage internal and external change controls.
  • Monitor and arrange oversight of actions under Customer Logistic Service QA responsibility or other third party used for transport and distribution.
  • Oversee the preparation, execution and follow up for external inspections, and report these into the relevant systems.
  • Monitor quality system performance versus local GxP and J&J requirements via use of pertinent business and compliance metrics and goals.
  • Perform regular internal and external audits per audit schedule and prepare audit reports according to procedures.
  • Perform regular supplier audits and prepare audit reports according to procedures.
  • Prepare, update and approve LOC procedures in accordance with local GMP/GDP, Business Quality Manual and J&J requirements and procedures.
  • Prepare, update and approve LOC procedures in accordance with local GMP/GDP, Business Quality Manual and J&J requirements and procedures.
  • Process and handle product quality complaints.
  • Assure effective processes to handle product and AE complaints, escalate critical product issues and conduct recalls and other field actions in a timely manner.
  • Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, the manufacturing plant QA, CLS QA, the logistic department, other Cluster / LOC in EMEA and any other functions.
  • Support the LOC management team in new product introduction and all other product portfolio lifecycle management processes.

Qualifications
Qualifications and experience of the successful candidate:
  • primary degree in Chemistry / Pharmacy / Microbiology / Medicine or a related scientific discipline;
  • at least 3 years’ experience in the Pharmaceutical industry, Quality Management 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;
  • 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.
  • Possibilities for further personal as well as professional development.
  • Work in a positive atmosphere with a highly motivated, energized team a good track level of success in business
  • Many employee benefits.

If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your CV and cover letter in English.


Primary Location
Czech Republic-Prague-Prague
Organization
Janssen-Cilag .s.r.o (8397)
Job Function
Quality (Generalist)
Requisition ID
1805658523W