Commercial Quality Head Janssen Jena
2 days ago
Johnson & Johnson Pharmaceutical is recruiting for a **Commercial Quality Head Janssen JENA **to be located in **Cairo, Egypt**.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Thriving on a diverse company culture, celebrating the uniqueness of **our employees** and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of **Our Credo**. It’s a culture that celebrates **diversity** and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
**Summary of the job:**:This position serves as a leader of quality and compliance and oversees the quality status of all regulated functions in the LOC.
The Quality Head is responsible for the implementation and maintenance of a Quality Management System (QMS) for regulated activities in the LOC (pre
- and post-marketing) and ensures, in collaboration with the various LOC 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 and that all applicable global, regional and local regulations are met in the LOC.
The Quality Head is the first point of contact for quality matters for the Managing director and local board of the LOC.
This function assures the quality and compliance of the product and services for the LOC markets.
**Duties & Responsibilities**:
- To define and implement the local quality strategy in line with regional CQ strategy and local business strategy including:
- Oversight, monitoring and improvement of the LOC quality and compliance metrics
- Proactively partner with other commercial departments to ensure quality aspects of new launches, delisting and divestures are properly handled.
- Work with functional partners to ensure alignment of commercial quality initiatives with strategic business direction.
- Identify and sponsor local initiatives/projects to increase compliance and to reduce the cost of non-quality / non-conformance.
- Identify and sponsor local cross-functional / cross-sector leveraging opportunities for J&J.
2. To lead and co-ordinate the development and deployment of an effective LOC QMS
- Coordinate the establishment and maintenance of the local QMS.
- Contribute to the one QMS at EMEA / WW level for the commercial organizations via providing LOC inputs to regional / global representatives and seeking feedback on project status. In case the Quality Head is the representative he/she actively collects regional feedback and provides updates to CQ EMEA / SLT.
- Ensure local processes are compliant and consistent with applicable J&J policies, global and sector standards, global and regional processes (as applicable) and all applicable global, regional and local regulations.
- Ensure local compliance oversight of the entire organization, in coordination with the other regulated functions (Regulatory, HCBI, Medial Compliance, Legal, PV).
- Ensure compliance oversight and proper local training for related research activities.
3. Responsible to obtain and maintain the required QMS compliance certificates, licenses and quality agreements for the LOC/cluster, including:
- Understand, document and explain the legal and quality set-up of the LOC: certificates, delegation of authorities, SLA’s, intra company quality agreements, quality agreements with external parties.
- Set-up effective collaborations with other functional areas such as SC QA, CLS QA, BRQC, EQ and PV to ensure reliable product supply that meets regulations.
4. To be the LOC lead for quality oversight and risk management via:
- Oversight and monitoring of complaints in an LOC / cluster.
- Triggering, leading and/or coordinating local, regional or global escalations and recalls regarding, product quality or compliance issues.
- Leading the local Quality System Management Review: Report to the Management Board of the LOC the performance of the QMS and the adequacy of the quality resources.
- Leading / coordinating for auditing and inspection. Ensuring that the LOC quality systems for the commercial organization are in constant state of readiness for planned and ad hoc audits or inspections.
5. To be the LOC point of contact for quality matters for:
- The local Managing Director and Local Board.
- The local leads for the regulated functions.
- All LOC employees involved in GxP quality and compliance activities (including commercial Janssen employees).
- Local Health Authorities, industry groups: Influence, alert and / or an
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