Commercial Quality Head
Posted on :
25-03-2024
Employer Active
1 Vacancy
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Job Description
Req ID : 2659180
- 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
- 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
- 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
- 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
- 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
- Manage the CLUSTER CQ organisation and resources
- Manage the CLUSTER CQ members reporting in full line to the CLUSTER QH: G&O, performance reviews, talent development, succession planning ...)
- Involve Regional CQ / CQ EMEA SLT for Cluster hiring and promotion of Clusters' CQ members
Employment Type
Full Time
Key Skills
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