Jsc Quality New Modalities Quality Head

Position Title: Janssen Supply Chain Quality New Modalities Quality Head
Supervisor Title: Vice President, Janssen Supply Chain Quality
Department Name: Janssen Supply Chain Quality
Physical Location of Role: Raritan, NJ, but other locations in PA and NJ, US and Beerse, Belgium may be considered.

**Position Summary**
The Janssen Supply Chain Quality New Modalities Quality Head is responsible for developing and leading a global, integrated E2E Supply Chain Quality strategy (including next generation and new cell therapies). The Platform constitutes a significant complexity as it transforms the way our supply chain is set up because of the intimate connect and direct impact on our commercial results. This position serves as a member of the Janssen Quality Supply Chain Leadership Team. In cooperation with the members of that team, the incumbent is responsible for developing/deploying the Quality strategic plan and assuring the integration/alignment of this strategy with the Quality Supply Chain strategy, Janssen Supply Chain strategy and Enterprise Quality.
- Develops and maintains an effective Quality process organization
- Leads the Global Quality Core Team in delivering effective operations
- Oversees Global Quality Leads and Quality Team for Vaccines and Advanced Therapies
- Drives oversight for internal R&D manufacturing sites (Bern and Leiden JVL)

Assures appropriate processes and resources are in place and effective to deliver a sound compliance (both from a Quality Assurance & Quality Control standpoint) profile to the sites within the New Modalities platform. Assure key JSC Quality processes are aligned and coordinated with marketing affiliates through Market Quality group. Assures that the quality process and systems to support suppliers are adhered to and maintained. Communicates expertise and guidance on relevant regulations, directives on standards and industry guidance related to quality system design and operation. Oversee adherence to metrics for Quality within and across business unit.

Ensures Quality programs are in place to onboard and train leaders and groups for effective program execution

In addition to developing and leading a global, integrated E2E Quality New Modalities strategy, the Quality Head is responsible for the strategic direction and performance of the quality operations and the initiation, planning and execution of the multiple (capital investment & integration) projects (a.o. new laboratory facilities, building the Lentivirus network, integration across DPDS (Drug Product Development and Supply; R&D), Commercial.

The Quality Head is responsible for the reporting out and getting endorsement from various stakeholders including: Platform VPs (Large & Small Molecule, External Quality) within Supply Chain Quality, Janssen Supply Chain Leaders within MTO, senior R&D and Commercial leaders, etc.

This role will be responsible for shaping the E2E Supply Chain Quality strategy to further build the Advanced Therapies Platform (complementing the Large and Small Molecule Platform) and functioning as one cohesive platform.

The Quality Head leads an expanding organization with global teams of sr. leaders managing through a matrix management model teams of direct and indirect reports.

**Major Duties & Responsibilities**
- Build the integrated E2E Novel Platform strategy. Direct and coordinate critical projects related to the business planning and the integration and alignment of the new modality Quality strategy. Ensure delivery of strong performance and meet the clinical and commercial targets at the same time making sure they can keep up with the expansion, innovation, and continuous improvement of the operations.
- Assures appropriate processes and resources are in place and effective to deliver a sound compliance (both from a Quality Assurance & Quality Control standpoint) profile to the sites within the New Modalities platform. Assure key JSC Quality processes are aligned and coordinated with marketing affiliates through Market Quality group. Assures that the quality process and systems to support suppliers are adhered to and maintained. Communicates expertise and guidance on relevant regulations, directives on standards and industry guidance related to quality system design and operation. Oversee adherence to metrics for Quality within and across business unit. Assure that appropriate metrics/targets are established, monitored and met, including removing barriers.
- Work as a member of the Janssen Supply Chain Quality LT to lead the New Modality Platform ensuring development and effective execution of the SC strategy, development of talent etc. (leading across). Forge effective partnerships with teams to drive the integration and alignment of the New Modality Strategy creating a focus on E2E approach, improvement, standardization and efficiency with respect to all activities across the platform. (Leading through influencing inside/outside of the Platform)
- Develop associates