GxP Systems Architect

7 days ago


Rockville, Maryland, United States 2072 BioReliance Corporation Full time

At 2072 BioReliance Corporation, we're on the hunt for a skilled GxP Systems Architect to join our team. This role offers an estimated salary of $120,000 - $160,000 per year.

About the Role

We're looking for a highly motivated individual to perform a variety of tasks within the Transformation Office and Quality department that are associated with maintaining regulatory compliance of GxP computer systems (and other business-managed applications) throughout their lifecycle.

  • The ideal candidate will participate in and/or lead project teams across global operational departments to implement business-managed applications.
Key Responsibilities

The GxP Systems Architect will be responsible for:

  • Performing administration tasks for a variety of GxP systems and associated software in a regulated (GxP) environment following defined procedures.
  • Defining, assigning, documenting, and managing user access across CTS.
  • Developing and implementing processes to ensure Data Integrity assurance: focusing on accuracy, reliability, and security across organizational systems.
  • Leading Software/System Development Lifecycle (SDLC) activities and managing Operational Technology (OT) deliverables (including but not limited to System Inventory management, Risk Assessment, Infrastructure Management, Data Classification and Protection, Data Privacy assessments, and Service Level Agreements).
  • Owning, managing, and maintaining GxP system lifecycle activities (including but not limited to Change management, SOP management, Events/CAPAs, Disaster Recovery and Business Continuity processes, Data Integrity assessments, and implementing Data Integrity controls).
  • Acting as liaison with wider business and collaborating between CTS departments on all SDLC activities (including but not limited to Validation, Change Management, Periodic Review, Decommissioning) for GxP computerized systems. Ensuring transition of OT Systems from project to operations.
  • Responsible for troubleshooting, incident management, servicing, maintenance, or other support functions for software or firmware associated with laboratory systems including OS upgrades, patch management, Infrastructure management, and system security.
  • Acting as liaison and interface between laboratory users, IT, OT, Engineering, Validation, and external vendors in selection, implementation, and lifecycle management of laboratory systems. Responsible for maintenance plan and contracts with vendors.
  • Responsible for timely communication of status of user requests and/or system outage reporting (e.g., helpdesk tickets).
Requirements

To be successful in this role, you'll need:

  • A Bachelor of Science/IT (B.S.) or Bachelor of Arts (B.A.) degree in science or technical area.
  • 2 years' experience in a technical role supporting regulated software applications or laboratory systems.
Preferred Qualifications

We're looking for candidates with:

  • Minimum of 3 years' experience in a regulated (GxP) environment.
  • Understanding of GxP regulations and guidelines, including but not limited to GAMP 5, US Code of Federal Regs. 21 CFR Part 11 and Part 211, Eudralex Volume 4, Annex 11 & Annex 15, ICH Q7, Q8, Q9 & Q10.
  • Acts ethically and ensures quality of own work and that of others.
  • Works with agility and willing to embrace and implement change on a global scale.
  • Applies technology to drive digitalization, improve quality, and increase customer value.
  • Excellent communication and facilitation skills (ability to lead cross-functional meetings, demonstrated ability to bring consensus among diverse cross-functional teams).
  • Proficient knowledge and application of FDA and EU regulations (cGMP, GLP).
  • Advanced knowledge and application of data integrity regulatory guidance (e.g., FDA, MHRA, WHO).
  • Understand quality standards for GxP software applications and systems.
What We Offer

We're committed to creating a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress. Join us in building a diverse team and explore what it means to us by visiting https://www.emdgroup.com/en/company/press-positions.html



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