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