EM Supplier SPOC

The EM SPOC (Site Point of Contact) position has cross region accountability for supplier management at External Manufacturers including, projects, issue management and process development/ improvement initiatives. This position may support the Global JSC organization by being the EM SQ point of contact for different stakeholders: External Manufacturer SPOC will liaise and collaborate with SQ Account Owners and EM Account Owners across the EQ organization to effectively manage and oversee supplier quality issues, under EQ- SQ responsibility, at External manufacturers. This position requires the ability to build and drive collaboration and teamwork across the EM sites and global EQ organization This oversight includes ensuring continuous compliance with relevant regulatory health authority requirements, effective risk management, strategy development and execution as well as effective cross functional collaboration between R&D, Operations, Procurement, TechOps, Regulatory Affairs and other technical disciplines (e.g., EHS). Negotiation of Quality agreements/JJQR’s with SQ and EM Account owners to ensure responsibilities of all parties are clearly defined and understood Supporting audits, technical visits, and proactive engagements at suppliers and external manufacturers, when appropriate. Overview and management of changes related to supplier and/or external manufacturers Coordination and assessment of deviations, supplier investigations, quality issues, corrective, and preventative actions (CAPAs), and complaints for suppliers of external manufacturers, including impact assessment of issues on other EM’s and /or JSC sites Provide supplier quality support to External manufacturing site during health authority inspections as needed Involvement in Change Management, escalations, compliance issues, recalls, field action that are related to suppliers and/or EMs Supplier Account Management (as appropriate) EQ-SQ member having the Quality oversight responsibility of the assigned Supplier, part of JSC Portfolio. Quality and Compliance lead ensuring quality standards are achieved and maintained at suppliers through management, and oversight on Quality Operations functions for external business partners. This position will primarily manage Highly Critical Suppliers (e.g., Increased Oversight) as: Surveillance on the quality and compliance status for primarily Highly Critical Suppliers (e.g., Increased Oversight) Activity support for the assigned suppliers on any related activities (e.g., impacted change control management / deviation / escalation / complaint handling / Specification alignment / Quality Agreement updating etc. ). Qualifications 8-12 years’ experience in biologics, drug product, drug substance, medical device, vaccines or similar regulated environment; preferred experience in Quality and Compliance. Required Minimum Education: Bachelor’s Degree In depth knowledge and experience with global regulatory, cGMP, and ISO requirements. Organizational leadership experience with demonstrated team collaboration and coaching skills. Demonstrated strategic thinking capabilities to define a vision for the future. Demonstrated experience with internal and/or external business partners. Excellent verbal and written communication skills, including ability to effectively communicate with internal and external partners. Excellent computer proficiency e.g., MS Office. Required Years of People Management Experience: 2-4 years of Direct or Indirect people leadership experience Primary Location Belgium-Antwerp-Beerse- Other Locations Europe/Middle East/Africa-Switzerland-Zug, North America-United States-New Jersey-Titusville, Asia Pacific-Singapore-Singapore-Singapore, Asia Pacific-China-Shanghai Organization Janssen Pharmaceutica N.V. (7555) Job Function Quality Requisition ID 2206061138W