Amicus Therapeutics

Quality Lead – Compliance and Operational Excellence

Amicus Therapeutics

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • 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.

Requirements

  • BA, BSc in a relevant field, such as Engineering, Sciences or similar.
  • Certification in lean Six Sigma (Green Belt or higher) or similar.
  • Experience in a GMP manufacturing environment.
  • 10 years experience in GxP or similar regulated environment.
  • Strong working knowledge of global regulatory and GxP requirements.
  • At least 5 years of experience in QA, compliance, complaints management, continuous improvement, operational excellence, or related field in the pharmaceutical industry.
  • Strong analytical skills and experience using lean Six Sigma, or similar tools and techniques.
  • Ability to work in a Global Environment.
  • Excellent communication and interpersonal skills, with the ability to build relationships and work effectively with stakeholders at all levels of the organization.
  • Strong project management skills, with the ability to manage multiple projects simultaneously and deliver results on time and on budget.
  • Experience of management of external partners and contract manufacturing.
  • Experience in working with global third party service providers and international call centers.
  • Experience in quality metrics reporting and analysis as well as process improvement techniques. Experience in reporting Complaints trends.
  • Excellent organizational, analytical, strategic, interpersonal, written and oral skills required.
  • Self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment is required.
  • Proficient with computer usage and applications such as Microsoft Word, Powerpoint and Excel.
  • Experience performing and supporting internal audits and Health Authority inspections