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仕事内容

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 to assume varied future opportunities. Partner with J&J leaders to assure development opportunities are afforded to key talent. Includes mentoring, coaching … etc. Hold leaders accountable for talent development. Provide leadership and development for his leaders and emerging talent. Drive a Credo based culture of innovation, engagement and development. (Culture and coaching and development)
  • Shape an E2E Supply Chain strategy to further build the Advanced Therapies Platform Explore synergies and barriers to supply chain and development interactions. Build processes to assure that appropriate touch points and hand offs are in place to assure overall organizational effectiveness.
Other Duties
  • Representing JSCQ in key business initiatives to build the New Modalities platform
  • Represent J&J externally at relevant industry forums


Qualifications

Required Qualifications:

Required Minimum Education: Bachelors Degree as a minimum
MSC/ MBA desirable
Required Years of Related Experience: 15
Required Knowledge, Skills and Abilities:
  • At least 15 years of senior level experience in quality management in a pharmaceutical and/or biotechnology environment with demonstrable experience leading large groups of professionals
  • At least 15 years of significant prior experience with Regulatory Authorities
  • Possess a working knowledge of analytical chemistry, microbiological test methods, chemical synthesis and/or biotechnological processing and pharmaceutical manufacturing technologies, cell/gene therapy or other new modalities required
  • Most recent experience should include senior level management overseeing multiple/complex sites/operations, across geographic regions. A diverse business and quality and working within different cultures, as well as handling diverse and complex market-specific issues, such as labor laws, healthcare regulatory requirement, tax laws and logistics. Proven experience in demonstrating strong financial acumen with respect to project evaluation and providing recommendations. Knowledge of Good Manufacturing Practices (GMPs), ISO, FDA regulations

Leadership Characteristics:
Business acumen
Understanding the pharma E2E quality process and is able to make decisions within this context
Making Complex Decisions
Can solve complex problems; great at gleaning meaning from whatever data is available; is a quick study of the new and different; adds personal experience and judgement to come to the best conclusion and solution in ambiguous situations, given the situation; uses multiple problem-solving tools and techniques.
Creating the New and Different
Is creative and can manage innovation; is an effective strategist full of ideas and possibilities; sees multiple futures; has broad interests and knowledge; can both create and bring exciting ideas to market; comfortable speculating about alternative futures without all of the data; and can deploy strategies that respond to a fast-changing environment.
Getting Work Done Through Others
Manages people well; gets the most and best out of the people he/she has; sets and communicates guiding goals; measures accomplishments, holds people accountable, and gives useful feedback; delegates and develops; keeps people informed; provides coaching for today and for the future.
Evaluating and Deploying People Effectively
Reads people accurately; can diagnose strengths, weaknesses, and potential; knows what skills are required to fill a job or role; hires the best; and enable people to reach their potential within the organization.
Communicating Effectively
Writes and presents effectively; adjusts to fit the audience and the message; strongly gets a message across.
Managing Diverse Relationships
Relates well to a wide variety of diverse styles, types, and classes; open to differences; effective up, down, sideways, inside, and outside; builds diverse networks; quick to find common ground; treats differences fairly and equitably; treats everyone as a preferred customer; and ability to influence people in a matrix environment
Inspiring Others
Is skilled at getting individuals, teams, and an entire organization to perform at a higher level and to embrace change; communicates a compelling vision and is committed to what needs to be done; inspires others; builds motivated, high-performing teams; understands what motivates different people.

Travel on the Job:
Yes
Percentage Traveled: 30%
Type of Travel Required: Domestic (US) and International

People Management Experience:
Yes, at least 15 Years of leading multi-disciplined teams


Primary Location
United States-New Jersey-Raritan-
Other Locations
Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey, North America-United States-Pennsylvania
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality
Requisition ID
2206064860W
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締切: 31-12-2025

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