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iZeal, Inc. is currently seeking an Supplier Quality Contractor / Supplier QualityLead for our client's requirement. The salary depends on experience. Job Title: Supplier Quality Contractor / Supplier Quality Lead Type: W2-Contract Location: Required Experience: The Supplier Quality Lead 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. The Supplier Quality Lead actively partners with stakeholders, individuals and teams, and external suppliers to implement innovative solutions and continuous improvements with demonstrated and measurable business results. Many of the activities of the role will require data management, organization, and analysis to uncover previously unidentified trends and insights which bring value of improved customer service reliability. The roles scope may be responsible and accountable within the Consumer Health and Vogue Quality Systems. The role will provide Supplier Quality support to the US Vogue business and may perform other related Supplier Quality duties as necessary. 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 and projects related to suppliers and materials utilized in products of multiple regulatory classifications (primarily Cosmetics, however may also include OTCs, NDAs, Class I Medical Devices, and Combination Products) and may include Chemicals, APIs, 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. Detailed responsibilities: 1)Supplier and/or Material Lifecycle Management, including: Subject Matter Expert (SME) in the selection, onboarding, monitoring, and disengagement of new and existing suppliers or materials. Activities may include Quality Agreements, Audit Remediation, Data/Metrics collection, Change Control and Specification review/approval, Approved Supplier List maintenance, and others as required by procedure. Leads the development and introduction of new process and procedures which may impact multiple functions or regions. Brings forward innovative process improvements to drive compliance and/or efficiency. Design and implement quality and compliance improvement programs and initiatives. Innovate solutions to significant quality systems gaps and lead continuous improvement projects. Independently manage and prioritize a highly complex and diverse workload, ensuring that deliverables are on-time, accurate, and meet their intended objective. Independent decision-making authority and accountability for material disposition and compliance decisions with significant impact to customer service. Engagement and support of cross-functional projects, such as material selection/onboarding initiatives, Sourcing selection/new supplier qualification projects, material governance, CAPAs, quality system improvement projects, and other initiatives. Provide detailed and/or summary communications to QA and cross-functional management on status of key initiatives and issues. 2)Supplier/Material Remediation and Reliability Improvement, including: Lead supplier engagements (Technical Assessments, FMEAs, Process Reliability, others); lead a cross- functional team, assess supplier current state, make recommendations for improvement, document results, and partner with supplier to address action items. Lead initiatives to engage with suppliers to drive remediation of open audit action plans, develop Risk Assessment and mitigation strategies to enable quality performance improvements. Develop and maintain working and collaborative partnerships with internal/external partners to enhance and sustain supplier/material reliability improvements. In partnership with internal or external partners, develop and implement initiatives to eliminate root causes of non-conformances or customer service disruption. Independently interact and partner with external senior leadership to negotiate and influence quality decisions, hold accountable for meeting Quality Responsibility Agreement requirements, and drive correction and continuous improvement of the suppliers quality system 3)Non-Conformance Investigations, CAPA, Material Event Escalations and Investigations :: Lead supplier or material non-conformance investigations, connecting with supplier to ensure robust supplier investigation and corrective actions, and partner cross-functionally to enable compliant event resolution. Troubleshoot high-risk / high-complexity quality /compliance issues, using experience, ingenuity, and creativity to provide solutions to a wide range of root causes. 4)Data Management and Analysis :: 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. Using historical indicators and insights developed from multiple data systems and partnership, implement proactive solutions to mitigate severity of, or prevent, the occurrence of material non- conformances or related events, at the local and global scale. 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, Data Analyst) or Supply Chain function (Planning, Sourcing, Operations); experience working in a Pharmaceutical, Medica Device, or Consumer Health industry is preferred.Experience with inspections or audits and developing actions plans to address deficiencies identified is preferredFamiliarity with root cause analysis, six sigma tools, or related methodologies is highly preferred Knowledge, Skills, and Abilities:Ability to successfully utilize Data Management tools and software to manipulate data is required (for example, Excel, Minitab, SAP, Etq, 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 (link removed)dependently 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 detailFluency in English. Educational Qualification: Minimum Bachelor's in Computer Science & Engineering or Equivalent Degree. Charitha Ch IT Recruiter iZeal , Inc. 46090 Lake center plaza, Suite#100, Sterling, VA - 20165.