Sr. Manager, Quality Systems Administration and CSV Compliance | BioNJ Talent Services

Sr. Manager, Quality Systems Administration and CSV Compliance

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 (CHART™) 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 Sr. Manager, Quality Systems Administration and CSV Compliance role will provide QA review/oversight for GXP computer systems. This position will oversee validation and strategies for the review and approval of executed validation documentation including protocols, report and test scripts. This role will manage the administration of GxP systems and associated discrepancies for EDMS.

Roles and Responsibilities
Experience in QA / Validation performing protocol review and approval associated with the implementation and maintenance of computerized systems in pharma/biotech environments.
Provide QA assessment and approval for GXP computer system changes.
Demonstrates in-depth knowledge of QA systems principles, concepts, industry practices, and standards.
Support and maintain Quality Assurance programs, policies, processes, procedures and controls ensuring compliance with cGxP expectations and established agency requirements/guidelines.
Oversees and investigates problems which occur and determine solutions or recommendations for changes and/or improvements and adherence to cGXPs.
Reviews, edits and approves change control and SOPs.
Acts as Quality contact and primary Subject Matter Expert (SME) for Validation and Quality Risk Management.
Manages validation contractors as required.
Ensures the site Validation Master Plan remains current and aligned with corporate policies and industry standards/expectations.
Develops and implements statistical tools for Quality Systems monitoring and review.
Reviews and approves changes to critical processes, facilities, equipment and systems through the change control program to assess impact on validated systems.
Collaborates significantly with cross functional groups, including Quality, Manufacturing, Process Development, Facilities, and Regulatory Affairs.
Provides technical assistance and training for personnel.
Other duties as assigned.

Qualifications: 

Requirements
Bachelor's Degree in technical discipline or related field with minimum of ten (10) years’ related experience.
Must have previous experience and proven track record of validating EDMS, Learning Management and QEM solution, preferably Master Control.
Strong understanding of the current pharmaceutical industry and applicable regulations, with emphasis in 21 CFR Part 11, 210, 211, 58 and 820 compliance.
Strong knowledge of appropriate Quality Systems and cGMP requirements (FDA, EU, ICH) with the ability to assess compliance risks.
Strong working knowledge in validation methodology and software development life cycle (SDLC) principles.
Must have excellent communication skills (both oral and written including the ability to effectively communicate across organizational levels and functions.

Experience and Skills
Knowledge of the Systems and CSV functions
Outstanding interpersonal relationship building and employee coaching and development skills.
Management experience in a team-oriented workplace, preferred.
Demonstrated ability to lead and develop a department and department staff members.

Travel
0-5%

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