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IT Compliance Supervisor

CARsgen Therapeutics Corpora

Durham, NC | Full Time

$80k-102k (estimate)

2 Months Ago

IT Compliance Supervisor

$80k-102k (estimate)

Full Time 2 Months Ago

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CARsgen Therapeutics Corpora is Hiring an IT Compliance Supervisor Near Durham, NC

IT Compliance Supervisor

TOGETHER, WE MAKE CANCER CURABLE

Led by an experienced management team of academic professionals and industry veterans, we have built an integrated cell therapy platform with in-house capabilities that span from target discovery, lead antibody development, clinical studies to commercial-scale manufacturing. Our vision is to become a leading biopharmaceutical company developing globally revolutionary cell therapies to make cancer curable. If you are looking for an opportunity with an innovative and solidly growing company, join us.

Responsibilities:

Responsible for creating standard operation procedures, protocols and compliance related documents for IT department in accordance with FDA regulatory and compliance requirements.
Responsible for the daily operation, troubleshooting, and maintenance of GMP-related information systems to ensure their normal operation and data integrity.
Work with user department on daily maintenance and provide support on equipment / instruments and associated system.
Participate in the testing, validation, and optimization iterations of computerized systems before they go live.
Collaborate with departments such as business and QA in handling quality incidents and providing technical support.
Support tasks related to system validation.

Qualifications:

5-8 years of pharmaceutical industry experience, specifically around IT audit, compliance, and IT operations.
Be familiar with FDA regulatory requirements on data integrity and data governance on computerized systems.
Familiar with FDA regulatory standards, possessing the capability to handle changes, deviations, CAPA (Corrective and Preventive Actions), and similar tasks.
Possesses the ability to conduct GMP audits for both internal and external purposes, familiar with related processes and biopharmaceutical regulatory guidelines.
Knowledgeable about QMS (Quality Management System), DMS (Document Management System), MES (Manufacturing Execution System), LIMS (Laboratory Information Management System), and WMS (Warehouse Management System) related information systems, with practical experience in implementation, validation, and operational maintenance.
Controls experience with systems development life cycle, access management, computer operations, networking, and security
Knowledgeable in information security and IT operations (including complex legacy infrastructure/application environments within the manufacturing industry)
Skilled in creating documentation, sharing technical information, and training less experienced team members.
Ability to work and communicate in a global business environment.

CARSGEN THERAPEUTICS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.

To all agencies: Please, no phone calls or emails to any employee of CARsgen about this requisition. All resumes submitted by search firms/employment agencies to any employee at CARSGEN THERAPEUTICS via email, the internet, or in any form and/or method will be deemed the sole property of CARSGEN THERAPEUTICS unless such search firms/employment agencies were engaged by CARSGEN THERAPEUTICS for this requisition and a valid agreement with CARSGEN THERAPEUTICS is in place. In the event a candidate who was submitted outside of the CARSGEN THERAPEUTICS agency engagement process is hired, no fee or payment of any kind will be paid.