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23 days old

Supplier Quality Lead

Kelly Services
Skillman, NJ 08558
Supplier Quality Lead


Long term contract with enhanced benefits


Skillman, NJ



Position Overview

The Supplier Quality Lead, Project Rubicon (Contractor), is responsible and accountable for the successful deployment and implementation of the Supplier Quality Management (SQM) strategy and associated policies, procedures, programs, and initiatives that deliver quality/compliance, material reliability, and/or operating benefit to the supply chain as it relates to Project Rubicon and associated SQM activities. Project Rubicon is a supply chain optimization project, with focus on implementing new or modified supply chains for new or existing materials.

This role is primarily responsible for qualification and onboarding of new suppliers (including distributors, re-packagers, re-labelers, and other external parties), scope extensions for existing suppliers, and related SQM activities. The roles scope includes North America but will also work on initiatives of multi-region or globally scale.

This role is responsible for various activities related to suppliers and materials utilized in products of multiple regulatory classifications (Cosmetics, OTCs, NDAs, Class I Medical Devices, and Combination Products) and will include primarily Chemicals and APIs, but may also include Packaging and/or Fiber/Non-Wovens. The role is responsible for complying with processes and controls, ensuring deliverables conform to established standards, and are in compliance with J&J policies and applicable Quality System Regulations and GMPs, such as 21 CFR 210 & 211, 21 CFR 820, and 21 CFR Part 11, EFfCI,and ICH Q7. This role is an integral member of project teams, either leading or as a team member, ensuring compliance and quality requirements are met in the oversight of suppliers from qualification through disengagement and implementation of new and modified raw material and/or packaging specifications. This role will take direction from more senior team members on the Supplier Quality North America team.


Project Rubicon Support for SQM activities will include:

Supplier and/or Material Lifecycle Management, including:

o Subject Matter Expert (SME) in the selection, onboarding, monitoring, and disengagement of new and existing suppliers or materials. A primary focus of the role is selection and onboarding of new suppliers or materials, but may involve supplier remediation and oversight activities in support of suppliers in qualification or already qualified.

o Project team meetings, reviews represent SQM perspective and SME on project teams

o Supplier selection and qualification activities as per applicable procedures and controls

o Quality Agreement negotiation with suppliers

o Initiation and follow-through of Change Controls related to supplier qualification and related activities

o Initiation and maintenance of supplier information records in data management systems such as Trackwise, maintenance of Approved Supplier List

o Audit qualification activities and deliverables

o Supply Chain verification activities

o Material and Supplier risk categorization

o Supplier remediation and performance monitoring as applicable

o Engagement and support of cross-functional projects, such as material selection/onboarding initiatives, Sourcing selection/new supplier qualification projects, material governance, Risk Assessments, CAPAs, quality system improvement projects, and other initiatives

o Engagement with J&J receiving sites (internal and external) to assess critical to quality attributes related to supplier/material performance in support of supplier selection, qualification, onboarding, or maintenance

o Material specification review and alignment with suppliers

o Provide detailed and/or summary communications to QA and cross-functional management on status of key initiatives and issues.


Supplier Remediation, Non-Conformance Investigations, CAPA, Material Event Escalations

o Lead supplier remediation activities to ensure suppliers are capable of meeting qualification requirements.

o As necessary, may lead or support material non-conformance investigations, connecting with supplier to ensure robust supplier investigation and corrective actions, and partner cross-functionally to enable compliant event resolution.

o Troubleshoot high-risk / high-complexity quality /compliance issues, using experience, ingenuity, and creativity to provide compliant solutions to a wide range of root causes.


Data Management and Analysis

o Analysis across multiple data systems to assess material/supplier performance metrics and partner closely with J&J manufacturing sites to identify supplier/material issues impacting performance and develop supplier engagement strategies to improve performance.




Qualifications

Education:

Bachelors Degree is required; a degree in a technical field (Engineering, Sciences, or similar disciplines) is preferred

Experience:

A minimum of 6 years of experience in a technical function (Quality Assurance, Engineering, R&D) or Supply Chain function (Planning, Sourcing, Operations);experience working in a Pharmaceutical, Medica Device, or Consumer Health industry is preferred

Experience working with external business partners on qualification, remediation, non-conformance resolution, or related projects/objectives is preferred

Experience with negotiating qualtiy agreements, contracts, or related agreements is preferred

Experience with inspections or audits and developing actions plans to address deficiencies identified is preferred

Knowledge, Skills and Abilities:

Ability to successfully utilize Data Management tools and software to manipulate data is required (for example, Excel, Minitab, SAP, Trackwise, or related software)

Detailed working knowledge of cGMP requirements and current FDA enforcement issues is highly preferred

Demonstrated ability to collaborate as a team member or team lead with internal/external partners to enhance relationships and interactions, including interfacing with management to inform, drive change, and provide direct feedback.

Independently prioritize a highly complex and diverse workload, ensuring timelines and objectives are met

Ability to value diverse perspectives and use that diversity to achieve results is required

A high attention to detail

Fluency in English


Other RequirementsLocation of Role: Skillman, NJ or Fort Washington, PA

Language Requirements: Fluency in English is essential

Travel Requirements: None (occasional travel to Fort Washington or Skillman dependent upon primary location)

Environmental Requirements: None

Physical/Work Requirements: None


The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. This description is representative of the knowledge, skill & ability necessary to carry out the requirements of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties of the job.



**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2022-04-29 Expires: 2022-05-30

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Supplier Quality Lead

Kelly Services
Skillman, NJ 08558

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