Sr Manager Eq

Il y a 5 mois


Geel, Belgique Johnson & Johnson Temps plein

**"Caring for the worldone person at a time” **inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable **Credo**

**Senior manager EQ - Supplier Quality**

**Responsibilities & Accountabilities**

This role ensures business, quality and compliance goals adhere to J&J policies, enterprise standards and government-issued environmental, health, safety, quality and regulatory policies and guidelines.

Represents the JNJ credo and quality values in contact with the suppliers and will comply with the JNJ regulations for ethic and business conduct to strengthen the reputation of J&J.

The responsibilities are within the EQ-SQ organization, that is the JSC quality unit responsible for Q&C oversight of suppliers in the Global Pharma sector and acts as quality partner for all API and DP JSC manufacturing sites.

This position requires high SME for all categories used at the corresponding to the JSC site.

This position may manage Contractors / SQ Team with Direct and Indirect reports.

**SPOC Role (40 - 50% of time)**:
SPOC (Site Point of Contact): EQ-SQ member to represent EQ (External Quality organization) to each JSC sites/Stakeholders/partners and to EMs located to ASPAC (with or without LOC involvement) where suppliers used are under EQ- SQ responsibility.

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 oversight includes ensuring continuous compliance with relevant regulatory health authority requirements, effective risk management, strategy development and execution as well as effective collaboration between R&D, Operations, Procurement, TechOps, Regulatory Affairs and other technical disciplines (e.g. EHS). Functions and activities include quality assurance review and approval functions (such as Change Control, Deviation Handling), compliance audit activities, creation and management of risk mitigation plans for suppliers.

This position requires complex stakeholder management, leading collaboration efforts between EQ and corresponding JSC site with the exposure to regulatory authorities’ inspections.

This position requires the ability of building collaboration and teamwork across the local and global JSC organization, and interfaces External Quality with the corresponding JSC site.

This position provides SPOC support and acting as a leadership role to Geel site (e.g. JSC Geel Site within Small Molecule platform).

**Account Owner (30 - 50% of time)**:
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.).

**Project Management (10 - 30% of time)**:
This position may Lead High Impact Projects typically from EQ (that could be linked to the annual company and division goals) or from Local JSC sites.

Lead and participate in strategic and optimization initiatives to improve EQ-SQ management processes.

**People Management (5 - 20% of time)**:
Directly managing, coordinates and coaching Contractors / SQ Team with Direct and Indirect reports

**GQRM Role (5% of time)**

This position may require the oversight/coordination of High Critical / Complex Suppliers as Global Quality Relationship Manager.

Act as Global Quality Relationship Manager for the assigned related Suppliers providing a single aligned voice for supplier quality performance within J&J enterprise network.

**Example of Jobs**
- Planning, execution, and documentation of the qualification and monitoring for suppliers who are sourcing APIs, API materials or DP materials such as excipients, raw or packaging materials, to the Janssen Supply Chain for the manufacture of Intermediates, APIs, or drug products respectively.
- Surveillance on the quality and compliance status for all suppliers under the Account Ownership
- Performing audits, technical visits, and proactive engagements at suppliers and external manufacturers
- Management



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