Commercial Quality Head Uk&ireland

4 months ago

High Wycombe, United Kingdom Johnson & Johnson Full time

At Johnson & Johnson, we believe health is everything. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, we’re empowered to tackle the world’s toughest health challenges, innovate through science and technology, and transform patient care.

All of this is possible because of our people. We’re passionate innovators who put people first, and through our purpose-driven culture and talented workforce, we are stronger than ever.

J&J Innovative Medicine (Janssen) is recruiting for a **Commercial Quality Head UK&Ireland **to be located in UK.

**_Role Purpose _**

This position serves as a local/cluster leader of quality and compliance and oversees the Commercial and Deliver activities of all regulated functions in a LOC / Cluster.

The Quality Head is responsible for the implementation and maintenance of a Quality Management System (QMS) for regulated activities in an LOC (pre and post-marketing) and ensures, in collaboration with the various LOC/Cluster 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 POL-001 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 / Cluster.

This function assures the quality and compliance of the product and services for the LOC/Cluster markets.

**_Key Role Activities _**

**1. **To define and implement the UK and Ireland LOC Commercial and Deliver quality strategy in line with regional CQ strategy and local business strategy including:

- Oversight, monitoring and improvement of the LOC / 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 functional partners to ensure alignment of business 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. 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 (CM).

**3. **Responsible to obtain and maintain the required QMS compliance certificates, licenses andquality 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, ESIQ and PV to ensure reliable product supply that meets regulations.
- Acts as the Controlled Substance Responsible Person for the UK LOC
- Acts as Quality Controller and Contact Person for the PQS under the UK MIA (IMP) licence.

**4. **Accountable for local release if mandatory by local regulations.

**5. **To be the LOC / Cluster 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 / Cluster 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.

**6. **To be the LOC / Cluster 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: Participate in Industry Association/Working Groups where present to anticipate, analyse current/

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