Manager Stability Third Party Manufacturers Job Vacancy at Johnson&Johnson Africa

Johnson & Johnson companies are equal opportunity employers.
Job Title:Manager Stability Third Party Manufacturers, JSC Stability Operations EMEA/AP-Product Quality Management-000005NZ

Description

(Keywords: Pharmaceutical - Chemical/Chemistry - Quality - Stability)

The Stability Operations team EMEA/AP is responsible for the management and execution of stability studies on Active Pharmaceutical Ingredients (APIs) and Drug Products manufactured and/or tested in Europe and Asia.
The scope of the activities of Stability Operations EMEA/AP will be expanded with the oversight of stability activities performed by more than 60 Third Party Manufacturing companies that are globally spread.  These Third Party Manufacturers (TPMs) produce APIs and Drug Products on behalf of the Local Operating Companies and the Janssen Supply Chain.

In the context of this expansion, we are looking for a Manager who will take on the following R&R's :

Role :  Manage the stability oversight of the globally spread TPMs

Responsibilities :

    Develop and install a stability oversight approach on stability activities performed at the TPMs
    Build a partnership with the Stability responsibles and Quality Executives at the TPMs to initiate and maintain an ongoing stability oversight
    Identify compliance risks in the area of stability at the TPMs and develop appropriate action plans in cooperation with the TPMs
    On an ongoing basis assure that the stability set-up and study management at the TPMs meet the regulatory requirements
    Provide support (advisory role) to the TPMs for setting up stability studies in function of changes in manufacturing processes, primary packaging materials, suppliers of excipients, …
    Build a partnership with the Stability Managers and Stability Integrators/Owners of JSC manufactured products, Quality Integrators/Owners and QA group External Supply Integration
    Operate within a global J&J framework with a globalized approach

Qualifications


    Minimum Master degree in the area of Chemistry, or equivalent by experience
    Minimum 5 years experience in quality control, quality assurance, stability and/or analytical development
    Global Regulatory and technical knowledge/expertise related to stability is an asset
    Knowledge of and experience with Good Manufacturing Practices
    Project management skills to build and maintain the required stability oversight
    Ability to effectively work in global and interdepartmental teams
    Affection to work in an intercultural and global environment
    Strong communication and interpersonal relation skills
    Ability to work independently
    Strong leadership skills in function of future extension of group and interacting with the TPMs
    Languages : English - fluent in reading, speaking and writing
    IT-Systems : experience with Office applications




Primary Location
 Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Other Locations
 Europe/Middle East/Africa, Asia Pacific
Organization
 Janssen Pharmaceutica N.V. (7555)

Travel
 Yes, 10% of the time

Job Function
 Quality Assurance
How to Apply;
http://careers.jnj.com/region