Commercial Quality Head Jena

4 weeks ago

مصر, Egypt Johnson & Johnson Full time

J&J Innovative Medicine is looking for a **Commercial Quality Head JENA **(Jordan & East North Africa) **to be located in Cairo (Egypt) and reporting to the Director Commercial Quality for Emerging Markets in EMEA.

**Overall purpose of the job**:
This position serves as a JENA leader of quality and compliance and oversees the quality status of all regulated functions in J&J Innovative Medicines JENA for established products and new launches (Commercial and Deliver-operational
- activities - hereinafter ‘CLUSTER’).

The CLUSTER Quality Head is responsible for the implementation and maintenance of a Quality Management System (QMS) for regulated activities in the CLUSTER (pre
- and post-marketing) and ensures, in collaboration with the various CLUSTER leads of the regulated functions (e.g. Quality Executives (GMP/GDP), local Safety Officers, Regulatory, etc.), that the implementation meets the requirements of J&J Quality Policy POL-001 and that all applicable global, regional and local regulations are met in the CLUSTER.

The CLUSTER Quality Head is the first point of contact for quality matters for the Managing director and local board of the CLUSTER.

This function assures the quality and compliance of the product and services for JENA.

**Main activities/tasks**:
1. To define and implement the CLUSTER quality strategy together with regional Commercial Quality (CQ) and assures integration and alignment with CLUSTER business strategy including:

- Oversight, monitoring and improvement of the CLUSTER 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 business partners to ensure alignment of commercial quality initiatives with strategic business direction (e.g. Serialization, new territories, new business development initiatives)
- Facilitate operational success of all GxP regulated functions within the CLUSTER
- 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 CLUSTER QMS that supports the business strategies:

- Coordinate the establishment and maintenance of the CLUSTER QMS
- Contribute to the one QMS at EMEA / EM level for the commercial organisations
- Ensure local processes are compliant and consistent with applicable J&J policies, global and sector standards and global and regional processes (as applicable)
- Ensure the CLUSTER is properly represented on global / regional quality projects & meetings
- Ensure quality related gaps are reflected in the Management Review for all GxP functions and mitigation actions are established by the responsible functions

3. Responsible to obtain and maintain the required compliance certificates and quality agreements for the CLUSTER:

- Understand, document and explain the legal and quality set-up of the CLUSTER: 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, RDQ, EQ and PV to ensure reliable product supply that meets regulations
- Accountable for controlled substances processes, reconciliation and HA notification in all markets of the JENA cluster as defined by local regulations
- Accountable for local release as mandatory by local regulations

4. To be the CLUSTER lead for quality oversight and risk management via:

- Oversight and monitoring of complaints in the CLUSTER
- Triggering, leading and or coordinating CLUSTER, regional or global escalations and recalls regarding product safety, product quality or compliance issues
- Leading the CLUSTER management review: Report to the Management Board of the CLUSTER the performance of the QMS and assure the adequacy of the quality resources
- Leading / coordinating for auditing and inspection. Ensuring that the quality systems for the commercial organisation are in constant state of readiness for planned and ad hoc regulatory audits or inspections

5. To be the CLUSTER point of contact for quality matters and quality role model for:

- The CLUSTER Managing Director and CLUSTER Board
- The CLUSTER and regional leads for the regulated functions
- All CLUSTER members involved in GxP quality and compliance activities (including commercial Janssen employees)
- Local Health Authorities, industry groups: Influence, alert and / or analyse current or emerging regulations that impact quality systems
- External stakeholders such as suppliers, distribution centres,
- Controlled Substance Responsible Person as defined in the related J&J procedure

6. Manage the CLUSTER CQ organisation and resources
- Manage the CLUSTER CQ members reporting in full line to the CLUSTER QH: G&O, performance reviews, ta

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