Lead manufacturing quality oversight for the Cardiff medical device value stream, ensuring compliance with ISO 13485 and driving continuous improvement.
Responsibilities
Monitor manufacturing quality performance using nonconformance, complaint, CAPA, right-first-time, process capability and Cost of Quality data to identify risk, establish priorities and drive improvement.
Provide Quality guidance and independent challenge across the medical device value stream, partnering with Operations and Engineering to maintain effective manufacturing controls and compliance with ISO 13485 and applicable requirements.
Drive effective resolution of nonconformances, deviations, complaints and CAPAs, ensuring appropriate containment, robust investigation, evidence-based conclusions and sustainable corrective action.
Provide Quality governance for manufacturing changes, equipment and process validation, product and process transfers, PFMEA and manufacturing risk management.
Make manufacturing quality decisions within delegated authority, escalating significant or systemic product, process or compliance risks with clear recommendations.
Requirements
Degree in Engineering, Science, Quality or a related technical discipline
Nice to have: Lead auditor
Nice to have: internal auditor
Nice to have: medical-device manufacturing transfers
External Quality is an agile organization that excels in quality and risk management, through building links with our internal team members and external partners. This role provides quality assurance support and oversight for external manufacturers involved in Synthetic drug products manufacturing.
Locations (3)
Latina, Lazio, Italy
Belgium
Switzerland
Compensation
The anticipated base pay range for this position is: €49’100.00 - €78’200.00
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.
Sr. Specialist External Quality
6084-Janssen Research & Development Legal Entity · Posted Nov 9, 2026
External Quality is an agile organization that excels in quality and risk management, through building links with our internal team members and external partners.
Locations (3)
Allschwil, Basel-Country, Switzerland
Beerse, Antwerp, Belgium
Latina, Italy
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.
Requirements
Bachelor’s degree or equivalent university degree in Pharmacy, Science, Engineering or a related technical discipline
Nice to have: experience working with external manufacturers
Nice to have: contract manufacturing organizations
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 elevate 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.
Requirements
Bachelor’s degree or equivalent university degree in Pharmacy, Science, Engineering or a related technical discipline
Nice to have: Experience working with external manufacturers
Nice to have: Experience working on cross-functional project teams
Nice to have: Experience with product transfer, new product introduction, parenteral, and/or combination products