Manager, Risk Management | BioNJ Talent Services

Manager, Risk Management

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury
Company Profile: 

Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We have a robust development pipeline of treatments for a range of human genetic diseases.

Our lead product candidate, migalastat, is a personalized medicine in late-stage development to treat individuals with Fabry disease on the basis of their genetic diagnosis. SD-101, a product candidate in late-stage development, is a potential first-to-market therapy for the rare genetic connective tissue disorder Epidermolysis Bullosa (EB). We are leveraging our biologics and Chaperone-Advanced Replacement Therapy (CHARTâ„¢) platform technologies to develop novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other Lysosomal Storage Disorders (LSDs). Our lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease ERT that will be administered in combination with a pharmacological chaperone.

Job Description:

Position Summary

The Manager, Risk Management will report to the Director, GCP, GLP and PV Quality Assurance (QA). The primary role of this position will be to support the Risk Management Team at Amicus and ensure compliance with ICH E6 (R2) guidance and international regulations. This role will also develop and document risk assessments which department GXP audit plans will be created against.

This position will be key in accessing system, process, and vendor risks and assisting in the planning, performance, tracking risk for global vendor/system QA audits.

Roles and Responsibilities

The Manager, Risk Management is responsible for:
Assisting with and documenting Vendor, Process and System Risk Assessments as required by ICH E6 (R2), EU directives and international legislation.
Maintain inspection readiness and documentation: risk assessments, audit plans, procedures and team minutes.
Participating in GXP audits/inspections of vendors, processes and systems. Maintain and file related documentation as required.
Review of gap assessments, audit reports, inspection activities and CAPAs to identify risk and recommend mitigation activities.
Attend meetings to support QA program development timelines and ability to meet key deliverables.

Qualifications: 

Requirements
A minimum of a BS preferably in chemistry or life sciences. A pharmacy, nursing and/or healthcare background is preferred.
Demonstrated knowledge of GXP applications in clinical trials and post-marketing commercial environments.
Minimum of 8 years of experience with increasing responsibility in bio/pharmaceutical (PV, GCP, GLP, RA) environment.
Experience conducting and reporting on PV, GCP and GLP quality audits and tracking CAPA.
Experience with vendor oversight and management.
Strong written and verbal communication skills, analytical problem solving and conflict resolutions skills.
Flexible, highly motivated, with strong organization skills and the ability to multi task. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment.
Ability to work independently and to make decisions based on education and experience.
Effective interpersonal skills.
Ability to travel domestically and internationally up to 10%.

Experience and Skills
Experience with Pharmaceutical GXP Quality and/or Regulatory Affairs.
Understanding of the ICH E6 (R2) update risk management requirements and ICH Q9 principles.
Ability to call and host multi-department meetings and gain agreement with attendees.

Travel
0-10% travel required

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Quality Assurance