Mallinckrodt Pharmaceuticals is seeking a Quality Manager for its Dublin facility to oversee the medical device Quality Management System (QMS), ensuring compliance with regulatory standards. The role includes managing quality-related activities, leading audits, and providing technical leadership in product development
Job Summary
This role is the Site Quality Head and Management Representative for the medical device Quality Management System (QMS) at Mallinckrodt Pharmaceuticals Ireland (MPIL).
The position focuses on deploying best in class quality leadership to ensure that activities, processes, and product at MPIL will meet current GMP standards and comply with applicable procedures, standards, regulations and the state of the art.
The scope of the position includes R&D projects, supplier management and Dublin quality systems (change control, CAPA, deviations, audits) activities.
Matching Summary
Match Score: 85
Mallinckrodt Pharmaceuticals is seeking a Quality Manager for its Dublin facility to oversee the medical device Quality Management System (QMS), ensuring compliance with regulatory standards. The role includes managing quality-related activities, leading audits, and providing technical leadership in product development.
Skills & Requirements
Must-have
Medical device Quality Management System (QMS)
GMP standards compliance
Regulatory agency interaction
Supplier quality management
Batch record review and release
EU MDR transition
CAPA and deviation management
Nice-to-have
Promote quality culture
Best practices application
Global QMS standardization support
Key Requirements
10 years' experience in a cGMP-regulated environment
Proven general leadership and quality management experience
Lead auditor certification and experience
Minimum 5 years' experience in a leadership role
In depth knowledge of ISO 13485:2016, ISO 14971:2019, EU MDR, MDSAP, 21 CFR 820, ISO 11135: 2014, ISO 10993-1:2018, cGMP