Senior Specialist External Quality

All Job Posting Locations

Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, Latina, Italy

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Quality

Customer/Commercial Quality

Professional

J&J Innovative Medicine is recruiting for a Senior Specialist External Quality to be located in Latina (IT), Beerse (BE) or Allschwil (CH). This role will report to the Sr. Manager External Quality. 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.

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.

• 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 escalation 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 registered requirements and patient supply needs are met.
• Support external manufacturers during J&J audits, health authority inspections and regulatory commitments, including preparation, response review and follow-up of agreed actions.
• Participate in technology transfer, new product introduction, product lifecycle management, process improvement and risk management initiatives for Synthetic products.
• Contribute to continuous…