Senior Specialist, Supplier Quality

Johnson & Johnson•Wilson, NJ

1d•Hybrid

About The Position

This role is part of a global team focused on supplier lifecycle management of over 3500 suppliers on behalf of 20 J&J Innovative Medicines sites globally. This includes supplier selection, audit qualification, risk management monitoring, and issue management with suppliers across the Biotherapeutics, Synthetics, and Advanced Therapies platforms. The role supports NPI growth, business continuity, and delivers on quality and compliance goals in compliance with J&J quality and regulatory guidelines. The position is responsible for developing Supplier Quality strategic priorities and leading execution of deliverables in collaboration with JJIM site personnel, SQ regional quality teams, and functional business partners such as Procurement, Planning, MSAT, and local JJIM Site Quality teams.

Requirements

A minimum of a Bachelor’s Degree is required.
BSc in Science, Engineering and Technical subjects is preferred.
E2E supply chain management or site based QA, QC, QMS experience
Knowledge on EQ/SQ QMS required to manage nonconformances, supplier investigations, change control and audits.
Position requires ability to build and drive collaboration and teamwork across regional sites and global EQ organization.
Minimum of 5 years’ in product / supplier lifecycle management across operating supply chain platforms including Biotherapeutics, Synthetics and Advanced Therapies.
Practical experience with GMP – and International Conference on Harmonization (ICH) regulation and direct experience of regulatory authorities’ inspections.
Must be able to travel up to 10%-15% of the time.
Strong understanding of Biotherapeutics, Synthetics and Advanced Therapies marketed products, including raw material management, DP/DS manufacturing processes, related compliance and quality system management.
Verbal/written communication skills that are effective across internal/external stakeholders and leadership teams.
Excellent analytical skill to identify gaps and root causes of issues and develop and communicate solution proposals.
Experienced working remotely and independently, self-motivated and comfortable operating within tight deadlines.
Ability to lead and influence in a high matrix environment
Bus Ex mindset – (Project management, change management, communications).

Nice To Haves

Coaching
Communication
Compliance Management
Controls Compliance
Cross-Functional Collaboration
Data Compilation
Econometric Models
ISO 9001
Issue Escalation
Performance Measurement
Problem Solving
Quality Control (QC)
Quality Standards
Standard Operating Procedure (SOP)
Technologically Savvy
Vendor Selection

Responsibilities

Owns supplier lifecycle management for a portfolio of suppliers including supplier selection, qualification, risk management, performance monitoring, issue management and compliance auditing.
Owns SQ QMS activities supporting lifecycle such as nonconformances, investigations, change control and audits.
Collaborate with JJIM Site QA teams on supplier performance and supplier material or services changes.
Deliver direct support to JJIM local Site during Customer, JJRC and HA inspections as needed.
Lead and maintain supplier relationships through business initiatives and compliance needs.
Support Supplier Quality project scoping and lead project management to achieve goals, objectives and cascade.
Shape supplier management practices for platforms with evolving or emerging complexities, or with hybrid supply chains, models, such as with advanced therapies, critical technology and software solutions providers.
Act as Supplier Quality Indirect Materials point of contact with site SPOCS related to indirect supplier management.
Project manage quality initiatives that have impact across JJIM site network in collaboration with site quality teams.
Deliver change management and communication updates within supplier quality on core activities and projects.
Build effective networks and act as SQ point of contact for Indirect Supplier / Services management with core partners.

Benefits

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Consolidated retirement plan (pension)
Savings plan (401(k))