Teams at Mallinckrodt Pharmaceuticals plc

Sells immunology and ophthalmology products to specialty physicians across an assigned Seattle territory. Builds relationships with opinion leaders, develops territory business plans, executes compliant clinical selling strategies, manages customer records, presents product information, and organizes programs such as speaker bureaus and symposia. Requires strong ophthalmology disease-state knowledge, business acumen, and documented sales success. Local travel and some overnight travel are required, along with attendance at regional and national conferences.

Supports the corporate compliance monitoring program by conducting transaction and live activity monitoring, reviewing and validating data, documenting observations, preparing reports, maintaining dashboards and compliance records, and tracking findings through closure. Collaborates with internal stakeholders and vendors, identifies compliance risks and process improvements, supports corrective actions and departmental initiatives, and escalates potential concerns. The role requires accurate documentation, analytical judgment, regulatory awareness, and proficiency with Microsoft Office, particularly Excel.

Leads the Madison site quality organization and maintains its medical device quality management system. Oversees QA staff, CAPA, investigations, management reviews, audits, inspections, regulatory submissions, vendor qualification, product transfers, design controls, change control, and medical device reporting. Serves as site management representative and PRRC, ensuring compliance with cGMP, FDA, ISO, and applicable device regulations. Requires extensive pharmaceutical, biotech, medical device, or diagnostic industry experience, including QA leadership and auditing.