GxP Systems Specialist
Glocomms is partnering with a leading, fast-scaling, and global biotech that is seeking a GxP Systems Specialist to support, administer, and enhance validated applications used across laboratory, quality, manufacturing, and other regulated business functions. This individual will partner with business stakeholders, quality teams, vendors, and IT colleagues to ensure systems remain reliable, compliant, and aligned with business objectives.
Responsibilities
- Administer, configure, and support GxP-regulated applications and platforms
- Gather business requirements and translate them into effective technical solutions
- Lead and support system implementations, upgrades, enhancements, and integrations
- Develop and execute validation documentation, testing protocols, and system lifecycle activities
- Support change control, CAPA, deviation management, and audit readiness initiatives
- Troubleshoot application issues and coordinate resolution with internal and external stakeholders
- Maintain system documentation, SOPs, validation records, and support materials
- Assist with data migrations, reporting, and system integration efforts
- Ensure compliance with regulatory, security, and data integrity requirements
- Drive continuous improvement initiatives across regulated technology platforms
Qualifications
- Bachelor's degree in Information Technology, Computer Science, Information Systems, Life Sciences, or a related field
- 5+ years of experience supporting validated systems in a regulated environment
- Strong experience with Computerized System Validation (CSV) and software development lifecycle processes
- Experience supporting laboratory, quality, manufacturing, or other GxP-regulated applications
- Knowledge of 21 CFR Part 11, GAMP 5, Annex 11, ALCOA+, and related compliance standards
- Experience with system integrations, APIs, databases, reporting tools, or data management solutions
- Strong analytical, troubleshooting, and problem-solving skills
- Excellent communication and stakeholder management abilities
- Experience with one or more of the following:
- LabWare
- LabVantage
- STARLIMS
- Waters Empower
- Watson LIMS
- Veeva
- MasterControl
- TrackWise
- Electronic Lab Notebooks (ELN)
- Quality Management Systems (QMS)
- Laboratory Information Management Systems (LIMS)
- High-impact role supporting business-critical systems in a regulated environment
- Exposure to enterprise applications and cross-functional initiatives
- Combination of hands-on technical support, system improvement projects, and strategic initiatives
- Opportunity to influence the future direction of regulated technology platforms
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
Yes, we help with resume and interview preparation. From customized support on how to optimize your resume to interview preparation and compensation negotiations, we advocate for you throughout your next career move.