Associate III, IT Quality

The incumbent works with peers to ensure practices are consistent with requirements and expectations set forth within the governing QMS; may support health authority inspections.

Responsibilities include but are not limited to:

1. Support the deployment of new or modified GxP systems through review and approval of life cycle deliverables in compliance with the governing regulations and procedures.

2. Under the guidance of management, perform supporting quality related activities associated with computerized systems including periodic reviews, change management, risk management, etc. for assigned systems in alignment with noted KPIs.

3. Working with senior members of the team, support SDLC activities for GxP applications – either enterprise platforms or functional specific applications).

4. Under the guidance of management, provide quality assurance oversight for system related issues (deviations, incidents, etc)

5. Support GxP audit readiness activities

6. Perform all assigned and required training to maintain 100% compliance.

7. Assist in the development and revision of IT controls templates.

*LI-POT7

5+ years related experience and/or training with at least 2 years in a CSV / Quality role. Background in Lifesciences and/or Pharma/Biotech industries.

Additionally:
•Experience supporting implementation of computerized systems within a GxP environme

As part of the IT Quality team, deliver technically robust and compliant GxP computerized systems (CS) that withstand audits, both internal and external. The Quality Associate III is expected to have working-level knowledge of CS validation, including the quality systems supporting it (i.e., change management, exceptions management, etc...). Foundational and executable regulatory expectations for CS. Works with peers locally to ensure practices meet the requirements and expectations of the QMS.