Johnson & Johnson Careers
Requisition ID: 1805653787W
Management of EMs for local and regional markets
- This position is responsible and has final accountability for the reliable, compliant and cost-effective supplies from 3rd party manufacturing for local and regional markets. Responsible to deliver OTIF, compliance, safety & environmental, COGPs, new product launch objectives.
- Work with fellow Quartet members with joint accountability to deliver business results.
- Negotiate, develop and manage supply contracts. Prepare Supply Agreements within the ESI Contractual Agreement framework.
- Lead and coordinate cross-functional/cross company tech transfers or new product introduction projects from development through launch.
- Responsible for EM selection and initial/periodic strategic analysis of the 3rd party overall process capabilities (financial, technical, compliance, and safety) to minimize risk to the supply chain and long term supply.
- Manage BCP and anticipate supply issues related to excipients, actives, packaging materials and ensure avoidance of supply disruptions because of short supply of these materials.
- Identify and deliver CIP’s or cost avoidance that result in lower unit cost. Prepare product rationalization financial analysis as necessary for products’ “end of life” situations, as well as product “upgrade” proposals.
- Identify opportunities and lead efforts to bring product in-house and/or consolidate EM sites to gain volume leverage, cost effectiveness and reduce complexity.
- Lead supplier development/partnership program and supply excellence initiatives.
- Manage packaging changes and brand extensions with JSC, J&J affiliates, and external manufacturers.
Manage Change Control Process
- The Change Control Lead supports the execution of change controls, CAPA, deviation, event, purchase orders management and project tracking processes that support JSC External Supply Integration in conformance to current standards and procedures, using applicable system application tools, e.g., Track Wise. In this role, the ESI Systems Analyst will:
- Coordinate and execute the completion of systems documentation for all systems requirements and processes in the regional External Manufacturing space.
- Partner with ESI Site Leads and other stakeholders (ESIQ, GTS, Regulatory, etc.) supporting External Manufacturing operations to ensure complete, timely and compliant closure of change control events.
- Work with Site Leads and senior functional leaders to facilitate solutions to issues and removal of barriers.
- Ensure appropriate risk management strategies and continuity of supply prioritization related to change control execution and completion.
- Ensure appropriate metrics are defined, measured and monitored key performance indicators for the ESI system management processes identifying opportunities for continuous improvement.
- Ensure audit readiness of global ESI system processes and documentation relative to the global compliance framework.
Coordination/leverage/ support Local for Local EMs
- The function works hand-in hand with the supply chain functions in the LOC who have the day-to-day interactions and execution with the local EMs. Provide oversight and leverage global EM processes.
- Support LOC on business development activities and coordinate sourcing business case preparations. Seek Global Sourcing Committee approvals on new/change of sourcing proposals.
- Coordinate governance process for local EM tech transfer projects managed by LOC supply chain functions.
- Oversees, support and leverage Business Continuity, Cost Improvement Projects, Life Cycle Management, EM Supplier Development and Control of Change programs at local EMs.
- Co-chairs business review meetings with local EMs.
- Lead and manage external supplier relationships.
- Any supply disruption will result in immediate and extended impact on revenues and reputation.
- New supplied products can be complex in terms of technology and manufacturing process and managing the learning curve is critical.
- Supplier relationships need to reflect and anticipate product demand uncertainty and industry change.
- Necessary to build trustworthy relationships and alliances with key EMs including regular business reviews with senior management to ensure J&J requirements are met.
- Maintain the system and process to facilitate efficient change control activities.
- Relevant procurement, supply chain management and pharmaceutical manufacturing experiences.
- Degree in sciences or engineering
- >5 years’ experience in pharmaceutical development and/or manufacturing
- General knowledge of relevant pharmaceutical and healthcare markets and industry.
- Close business relationships and intelligence of CMO and supplier network
- Expertise in manufacturing processes and regulatory requirements.
- Involving people in issues that affect them. Facilitating dialogue between team members so they understand the links between their different ideas and perspectives. Bringing team members into the discussion so they can contribute their ideas.
- Forming win-win partnerships with internal stakeholders. Showing how a plan or strategy can be mutually advantageous in order to gain cooperation. Overcoming objections and progressing business objectives.
- Seeking to raise levels of performance by establishing an improvement process, or setting specific, measurable targets and goals linked to J&J business needs.
- Taking initiatives (a clearly interconnected set of activities) designed to raise the ‘value added’ to customers. These activities will have a wider or longer-term effect than a specific action designed to address a particular customer issue or problem
- Good verbal and written communication skills, potential requirement for local language. Good business English required.
- Ability to develop EM management and development strategies to ensure continuous improvement in EM performance.
- Good knowledge on change control system such as Trackwise.
Johnson & Johnson Pte. Ltd. (8435)