Amicus Therapeutics

Compliance

• Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.
• The Quality Lead, Quality Compliance and Operational Excellence will oversee the Global Process for Product Complaints for Marketed Products and Clinical Trails and will also assist to drive organizational performance through workforce empowerment using collaboration, proven lean six-sigma tools, and change management methodologies.
• This role will emphasize compliance with SOPs and applicable regulations. They will interact with key stakeholders in the organization for timely and accurate receipt of complaint reports. This role will lead/facilitate complaint investigations, report complaint trends and escalate issues to Management. They will lead the training of Amicus personnel for the responsibilities and requirements for the identification and handling of complaints. This role will also interact with Health Authority inspectors as the Global Complaints Process Lead/SME.
• They will assist with supporting and developing a Quality Compliance and Continuous Improvement culture ensuring that Global Quality Operations are carried out in a compliant and efficient manner including leading and/or facilitating internal audits.
• They will compile and author Annual Product Quality Review (APQR) global summary reports for all commercial products.

Quality Lead – Compliance and Operational Excellence