Quality Specialist ESIQ – EMEA

Descrizione dell'offerta

External Supply Integration Quality (ESIQ) is a Global Quality organizational unit of Janssen Supply Chain which provides leadership and owns Quality and Compliance oversight on suppliers and external manufacturers who supply either materials for Janssen drug products or manufacture finished drug products for Janssen.

For our ESIQ-Organization, we are looking for a Quality Specialist EMEA who will manage from a QA & Compliance point of view the pharmaceutical third party manufacturing operations in the EMEA region.

Role and main responsibilities:

· Maintain or build partnership with the QA counterparts of External Manufacturer and with the other External Manufacturing stakeholders within JNJ (such as PES - Partnership & External Supply - GTS - Global Technical Services - Compliance, Regulatory, L&A, Logistics).
· Assure that the manufacturing operations for JNJ at the External Manufacturers run smoothly from a QA point of view and in a compliant way. Assists in the development, implementation and review of standard operating procedures for interactions with contract manufacturers.
· Pro-actively identify risks and potential issues and delays and where possible resolving them. Makes proposals and assists in the development of corrective action plans and monitors implementation. Follows up on closure of corrective and preventive actions.
· Ensure that all relevant QA related concerns of the External Manufacturing Organisation are raised at the relevant levels within JNJ.
· Prepares for and facilitates audits and inspections.
· Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time. Provides quality support for technology transfer and improvement of existing manufacturing processes.

Profilo richiesto

Qualifications :

·  Bachelor's or Master's degree in either life science discipline, e.g. Chemistry, Pharmacy, Microbiology or Engineering
·  Minimum 3 years of experience in Quality or Operations departments
·  Excellent influencing and interpersonal skills (communication and listening skills) as well as teaming with third party suppliers to identify and ensure that J&J best practices - or adequate - are utilized
·  Able to work virtually connecting with other sites, customers and global functions
·  Ability to influence and interact at multiple levels of the organization
·  Strong ability to manage problems and urgencies during issue management
·  Ability to manage multiple priorities and deliver excellent results
·  Excellent written and verbal communications skills (In English)

The resource will be based in Latina – Borgo San Michele, and will travel 20% of the time.