HireDiversity

Geel, BE

Quality Owner-000007FU

Omschrijving

For our Chemical Site in Geel within the departement Quality we are currently recruiting for a

Quality Owner

Your function

You have the end-to-end accountability for the quality strategy and quality aspects of commercial products for an assigned portfolio of products:
- Serve as the single point of Global Quality contact for an assigned group of marketed products
- Responsible for ensuring end-to-end Quality for assigned products across DS site(s), DP site(s), packager(s) and QC testing and release
- Know the product history and understand the processes across the various manufacturing sites
- Assure Quality milestones and Quality deliverables are achieved, and approve content of spec changes to ensure spec changes are aligned end-to-end
- Represent Global Quality on the Value Stream Teams and maintains the flow of communications between Global Quality and Value Stream Teams
- Bring Quality issues to the Value Stream Teams and assist with prioritization of projects and with key product decisions
- Support the business continuity process including VST strategy
- Review Proactive Product Quality Scans with the VST and assure appropriate mitigating actions are defined there
- Define and oversee the necessary Quality resources for global and local of the assigned products
- Lead a comprehensive Quality Sub team that assures Quality throughout, DS, DP, Fill Finish. Support the sites and represent the sites.
- Assure product quality over the life cycle, understand the performance, and risk profile, throughout shelf-life
- Support preparation of the criticality analysis per schedule. Review and sign of criticality assessments.
- Ensure complaints are well managed, issues are understood, and trends in Global Medical Safety, are understood and addressed as necessary. Participate in product safety management teams
- Coach local QA people who have API quality ownership of a product.
- Interact closely with PQM group to ensure training needs for Geel are met and global processes for QO's, R&R's are fully understood

In case the candidate holds a pharmaceutical degree, the quality owner will become a delegated QP for the spraydried products manufactured at the Geel site.

Review of approval of PQR's of comercial intermediates and API's manufactured in Geel, as delegate of the Director Quality Assurance.

The function will have a direct reporting line into the Geel site quality organization (to Director of Quality Assurance) and a dotted reporting line to the Sr. Director PQM

Kwalificaties
- A minimum of a Bachelor's degree in a pharmaceutical, chemical, biological, or related/relevant discipline, preferably industrial pharmacist to be able to act as delegated QP next to Quality Owner role.
- A minimum of 8 years experience in the pharmaceutical industry with the necessary background to make decisions on quality aspects in projects is required.
- Knowledge in cGMP, standards, policies and procedures is required.
- Knowledge of domestic and international GMP is required.
- Experience with Quality content of Regulatory filings (questions and responses) is preferred.
- The potential to acquire a wide range of technical knowledge in DS, DP, packaging for the products they represent is needed.
- A demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering is needed.
- Relationship building, partnering and influencing in a matrix organization will be required.
- Negotiation, communication and presentation skills across all levels are important.
- The ability to quickly assimilate new technologies, perform risk assessment and develop action plans is required.
- The ability to understand the business implications regarding quality positions and decisions is needed.
- Speaks/Writes English fluently and preferably has basic understanding of the Dutch language.

Primaire locatie: Europa/Midden-Oosten/Afrika-België-Antwerpen-Geel

Organisatie: Janssen Pharmaceutica N.V. (7555)

Functie: Kwaliteit