# Sr. Specialist External Quality at Johnson & Johnson

Johnson & Johnson is hiring a Sr. Specialist External Quality. Level rates it Little AI ●○○○; you can [apply on Johnson & Johnson](https://jobsbylevel.com/go/0c01877a-9597-4356-90d4-ca2fcd9ebf12?utm_medium=ai-agent).

AI Level 1, AI centrality 38 out of 100. Latina, Italy.

## Details

- Company: [Johnson & Johnson](https://jobsbylevel.com/companies/johnson-johnson)
- AI level: AI Level 1 (score 38 out of 100)
- Location: Latina, Italy
- Posted: November 9, 2026
- Apply: https://jobsbylevel.com/go/0c01877a-9597-4356-90d4-ca2fcd9ebf12?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=sr-specialist-external-quality-at-johnson-johnson-51fca9

## Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Belgium R-109826, Italy R-109827, Switzerland R-109772 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Latina, Italy Job Description: External Quality is an agile organization that excels in quality and risk management, through building links with our internal team members and external partners. In this role, you will play a crucial part in maintaining the highest quality and compliance standards for our Synthetic products, specifically focusing on Drug Products, produced at external manufacturing sites. You’ll collaborate closely with our External Quality Site Lead and be a champion for quality in everything we do! The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance. Essential Job Duties and Responsibilities This role supports business, quality and compliance objectives for externally manufactured Synthetic drug products, ensuring activities are performed in accordance with J&J policies, enterprise standards, quality agreements, cGMP requirements, ICH expectations and applicable regulatory commitments. The Senior Specialist EQ provides quality assurance support and oversight for external manufacturers and strategic partners involved in Synthetic drug substance and/or drug product manufacturing, packaging, testing, release, stability and supply activities, while helping to maintain product quality, compliance and reliable patient supply. Key Responsibilities: Provide quality assurance support and oversight for external Synthetics manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities. Review, coordinate and provide quality concurrence or approval, as applicable, for deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition records, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements. Monitor quality and compliance performance of assigned external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history, supplier performance data and issue trends. Identify, communicate and escalate quality, compliance or supply risks in a timely manner and support practical, risk-based mitigation and remediation plans. Support qualification, ongoing monitoring and lifecycle management of external manufacturers and strategic partners in alignment with External Quality processes. Collaborate with External Quality Site Leads, Product Quality, MSAT, Planning, Procurement, Regulatory, EHS, Qualified Persons and external partners to ensure

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Source: https://jobsbylevel.com/jobs/sr-specialist-external-quality-at-johnson-johnson-51fca9

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Level. https://jobsbylevel.com/jobs/sr-specialist-external-quality-at-johnson-johnson-51fca9.

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