IT Compliance Manager

1 week ago


Rensselaer, New York, United States RCM Life Sciences and IT Full time
The Senior QA Specialist plays a vital role in ensuring the accuracy and reliability of software applications. As a Subject Matter Expert (SME), you will support investigations, risk assessments, and IT operations while verifying that GxP computerized systems operate as expected post-validation.

The key responsibilities of this role include:
* Ensuring IT processes and procedures meet Quality System requirements
* Participating and supporting the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives
* Providing support and guidance with quality system records activities such as change controls, corrective and prevention action plans (CAPAs), risk assessments, data integrity initiatives, deviations, internal and external audits, standard operating procedure (SOPs), work instructions/job aids, policies, etc.
* Providing ongoing support to the Quality Auditing function with respect to IT vendors and audits
* Supporting the development, review, and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process
* Collaborating with other functional areas to collect information and provide guidance through all stages of the quality management system and improvement projects
* Ensuring new systems/processes/procedures are compliant with SOPs, WIs, and data and regulatory guidelines for IT and Software validation processes
* Assisting in resolution of inspection management concerns as it relates to software applications process, procedures, and data integrity

To be successful in this role, you must have a strong background in quality assurance and IT compliance, with a proven track record of ensuring the accuracy and reliability of software applications. You should also have experience working in an FDA regulated environment with a strong emphasis on a risk-based approach to validation/qualification. Additionally, you should have a strong knowledge of FDA CFRs, Eudralex, and other biotech/pharma industry regulations (pertaining to IT, laboratory systems, automation, and manufacturing), as well as a strong knowledge of Data Integrity, System Development Life Cycle (SDLC) validation methodology, and Software Quality requirements.

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