Manager, Clinical Quality Assurance | BioNJ Talent Services

Manager, Clinical Quality Assurance

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

COMPANY PROFILE
We are passionate about what we do
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, Clinical Quality Assurance will be responsible for: (i) auditing sponsor processes, trial master files, investigator sites, and vendors (e.g., CROs) under the guidance of a senior member of the department, and (ii) ensuring quality activities are performed and documented in compliance with corporate policies and standards, and all applicable global regulations with minimal supervisory oversight.

ROLES AND RESPONSIBILITIES
The Manager, Clinical Quality Assurance will be responsible for:
Conducting GCP Risk Assessments.
Assisting in the development and implementation of the annual QA-GCP audit plan using a risk-basedapproach.
Developing an audit agenda and communications (e.g., pre-audit document requests) with auditees for each assigned auditproject.
Conducting audits and meeting the following requirements:
Ensure timelines for completion of audits are met.
Comply with all applicable SOPs, policies, global regulations, etc.
Escalate audit issues/concerns to QA management.
Produce audit reports and corrective action tables.
Develop status reports with key metrics on audit progress.
Issues applicable audit certificates.
Maintain accurate and timely documentation of assigned QA activities.
Preparing with line functions and QA management in the development of corrective action plans.
Analyzing and report trends in audit findings, as requested.
Reviewing and assess key metrics (i.e., quality of TMF structure, risks, time for project, etc.).
Assisting in the development of training forauditees.
Acting as a QA representative in program and protocol team meetings.
Maintaining knowledge on industry leading practices and current regulations surrounding GCP compliance.
Participating in regulatory inspection activities for sponsor and sites.
Other QA-GCP activities as assigned

Qualifications: 

REQUIREMENTS
Bachelors degree within a scientific discipline.
A minimum of 8 years in the Pharmaceutical/Biotechnology industry is required with at least 3 to 4 years of GCP auditing experience preferably in relation to sponsor, site, and vendor audits.
Pre-Approval Inspection readiness audit experiencerequired.
Experience in clinical operations and handling trial essential documents ispreferred.
Strong knowledge of global regulatory requirements for clinical trials and ICH/GCP/GLP guidelines.
EXPERIENCE AND SKILLS
Solid written and verbal communication skills, analytical and problem solvingskills.
Flexible, highly motivated, with strong organization skills and the ability to multitask.
Be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamicenvironment.
TRAVEL
20-30% domestic and international

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Clinical Operations
Paid: 
Yes