Manager, CAPA Systems QA | BioNJ Talent Services

Manager, CAPA Systems QA

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

Amicus Therapeutics (Nasdaq:FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases.

With one rare disease medicine globally commercialized for Fabry disease, an investigational enzyme replacement therapy (AT-GAA) in late stage development for the treatment of Pompe disease, and a robust gene therapy pipeline and growth platform for lysosomal storage disorders, Amicus Therapeutics is committed to changing the lives of people with these life-threatening conditions.

Job Description:

Summary of Position

The CAPA Manager is responsible for the global management and overall effectiveness of the Corrective and Preventive Actions (CAPA) process. This role will also drive these processes for QA with emphasis on compliance to SOPs and applicable regulations. The CAPA Manager will interact with key stakeholders in the organization. This role will provide guidance on CAPAs, report CAPA trends, and escalate issues to Management. This role will lead the training of Amicus personnel for the responsibilities and requirements for the identification and processing of CAPAs.

Roles and Responsibilities
Provides quality oversight of the CAPA process and conduct on-going CAPA training.
Assist/Interface with CAPA owners on CAPA Root Cause Investigations and Action Plans.
Providing status reports, including relevant metrics to department management and follow-up on CAPA items to ensure timely completion.
Monitors the effectiveness of the CAPA system.
Maintain the CAPA system, evaluation process flows and work to ensure business processes are translated appropriately into an automated solution.
GXP CAPA management ensuring adherence to company policies/procedures and GxP regulations and are reviewed by applicable CAPA Board stakeholders
Support the CAPA program in internal/external audits and regulatory inspections.
Author, review and approve related policies and procedures.
Coordinate CAPA review board meetings and track agenda items and minutes.
Maintain current knowledge of industry standards and regulatory requirements for products developed by Amicus.
Administrative duties include but are not limited to the monitoring of information relative to problem statements, root cause analysis, immediate corrections, corrective and preventative actions, tracking of time lines, and establishing CAPA files.
Perform other duties as assigned.
Support Quality Management System and Quality projects/initiatives.
The CAPA Manager will report to the Director, Quality Management & GxP Systems

Qualifications: 

Qualifications and Background Requirements
BA or BS in related technical field is required
A minimum of 5 years’ experience in the field of root cause analysis and CAPAs
A good working knowledge of worldwide GxP compliance regulations is preferred
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
Demonstrated strength in influencing and negotiation skills and ability to communicate effectively at all levels of the organization is required
Ability to perform in a team and matrix organization, as well as adapt to a dynamic environment is required
Strong communication and personal leadership skills with demonstrated competency interfacing with senior leaders required
Proficient with computer usage and application such as Microsoft Word, Powerpoint and Excel

Travel

Ability to travel domestically and internationally up to 5-10%

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