Senior Specialist Eq Supplier Quality
hace 3 semanas
Janssen Supply Group, LLC is recruiting for a Senior Specialist, EQ Supplier QualityRemote work options may be considered on a case-by-case basis and if approved by the Company.We are part of the Janssen Supply Chain (JSC), a global organization responsible for supplying medicines to markets and patients around the world.With Supplier Quality as our primary focus, we strive to provide access and affordability through innovation and collaboration with our Internal Sites, Procurement, R&D, and other Commercial partners to deliver life changing solutions for patients in need.Are you ready for a new opportunity within our organization?As a Senior Specialist within EQ Supplier Quality, you will ensure quality and compliance for suppliers in adhering to policies, enterprise standards and regulatory guidelines.As Janssen is part of Johnson & Johnson, you will represent the J&J Credo and its Quality Principles.**Key Responsibilities**:- Manage a portfolio of suppliers including performing of supplier qualification activities; primarily for suppliers within both the U.S. and Mexico.- Be responsible for quality engagements with suppliers to identify and implement improvements regarding their performance, quality, and cost.- Document risk assessments of a supplier's quality systems by the means of on-site audits, questionnaires, or other tools to assure the quality and conformity of supplied materials.- Be involved in assessing the impact of supplier change management, non-conformances, compliance issues, and corrective actions.- Establish and perform periodic review of Quality Agreements.- Lead and participate in projects and optimization initiatives to improve supplier management processes.- Collaborate with partners such as Site Quality, Operations, Procurement, R&D, and Regulatory Affairs.**Qualifications** Education**:- A Bachelor's degree or equivalent University Degree is required.**Experience and Skills**:**Required**:- 6 or more years of related work experience.- Experience in quality management, production, quality control, or R&D in a pharmaceutical and/or biotechnology environment or similar.- Knowledge and experience with cGMP regulations and ICH guidance.- Fluent in both Spanish and English.- Capable of working remotely.- Must be available for travel for up to 25%.**Preferred**:- External auditing experience as a lead auditor.- Experience handling the quality oversight of external suppliers or manufacturers, including selection, qualification, and monitoring.- Experience using risk management strategies and tools.- Experience with change control, investigation & complaint handling, corrective actions, and quality agreements.- Experience collaborating in a highly cross functional environment including interacting with areas such as Site Quality, R&D, Operations, Procurement, and Regulatory Affairs.- Exposure to regulatory authority inspections.**Other**:- Relocation assistance is not available for this role.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.**Primary Location**United States-Texas-El Paso-425B Pan American Drive**Other Locations**United States-Texas-San Antonio, Mexico-Chihuahua-Juarez**Organization**JANSSEN SUPPLY GROUP, LLC *****)**Job Function**Quality**Requisition ID************W
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