Job Function:
Quality

Job Sub Function:
Supplier Quality

Job Category:
Professional

All Job Posting Locations:
Athens, Georgia, United States of America, Gurabo, Puerto Rico, United States of America, Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Remote (US), Wilson, North Carolina, United States of America

Job Description:

We are searching for the best talent for Senior Specialist, Supplier Quality to join our Innovative Medicine External Quality/Supplier Quality team located in Raritan, NJ; New Brunswick, NJ; Malvern, PA; Horsham, PA; Athens, GA; Wilson, NC; or Gurabo, Puerto Rico.

Remote work options may be considered on a case-by-case basis and if approved by the Company. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Within the JJIM Supplier Quality group, this role is part of a global team focused on supplier lifecycle management of >3500 Supplier's on behalf of 20 J&J Innovative Medicines sites globally, including responsible for supplier selection, audit qualification, risk management monitoring and issue management with suppliers across the Biotherapeutics, Synthetics and Advanced Therapies platforms. This role is also tasked with supporting NPI growth, business continuity and delivering on quality and compliance goals in compliance with J&J quality and regulatory guidelines.

Essential Job Duties and Responsibilities

Core responsibilities include development of 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.

Core Responsibilities: (include but are not limited to)

• 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.

Minimum Qualification/Experience

• 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.

Competency/Skill Requirements:

• 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).

If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent's consent for the background check.

#LI-Hybrid

#LI-Remote

Required Skills:

Preferred Skills:
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

The anticipated base pay range for this position is :
$94,000.00 - $151,800.00

Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days

Volunteer Leave - 32 hours per calendar year

Military Spouse Time-Off - 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits