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PURPOSE

The Supplier Risk Management, Senior Specialist is a member of the Supplier & Vendor Quality group in R& D Quality (RDQ). This role is to assist in the execution of GxP supplier risk management activities to ensure quality of the GxP system, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness. May lead targeted activities as directed by SVQ management

MAIN REPONSIBILITIES | DUTIES

Main responsibilities will include, but are not limited to:

Business Advisor & Portfolio Oversight

• Manage the Janssen R& D Approved Supplier List (ASL) including addition of newly qualified suppliers, maintenance of active suppliers and disengagement of inactive suppliers
• Facilitate periodic functional review of Approved Supplier List to confirm all GxP impacting suppliers are included

Risk Management & Governance

• Support activities contributing to the review of key risks associated with GxP suppliers and provide input to the design of effective mitigation strategies. May support supplier management activities as assigned by SVQ management
• Support development and implementation of standard operating procedures (SOPs) for supplier management that align with local regulatory requirements, JnJ standards and internal processes and procedures
• Lead quality process and system improvement initiatives related to the R& D ASL. Support broader SVQ quality process and system improvement initiatives as assigned by SVQ management
• Lead/support supplier qualification activities and supplier audits as assigned by SVQ management

Team Leadership & Execution

• Support or lead local / regional or global projects and quality initiatives as assigned by SVQ management

REPORTING STRUCTURE

This position will report to the Supplier & Vendor Quality, Director.

EDUCATION | QUALIFICATIONS

• BA/BS or equivalent, BS degree in scientific discipline or business is beneficial
• Advanced degree in science or business is preferred
• 6 years of related experience in a medium- to large-scale, life sciences organization
• Compliance experience in a related area or GxP regulated discipline
• Demonstrated experience engaging key stakeholders
• Ability to travel up to 25%, primarily domestic

SKILLS | COMPETENCIES

• Innovative mindset to build and maintain a competitive advantage
• Ability to negotiate, influence and lead without direct line authority
• Ability to engage and align with Janssen R& D functions
• Ability to motivate colleagues and stakeholders at all levels of the organization
• Conflict resolution, management, and negotiation skills
• Exceptional written and verbal communications skills in English
• Strong project management and execution skills
• Ability to interpret data to develop action plans to improve business