About this opportunity
YOUR ROLE:
Join our dynamic team to ensure our GxP computer systems and lab software remain compliant across their entire lifecycle. In this hands-on position, you’ll handle system administration, manage user access, maintain critical quality records, and perform essential software troubleshooting. You'll act as the key liaison between laboratory users, IT, Validation, and external vendors to drive seamless system implementations and upgrades. Working across global departments, your expertise directly protects data integrity and streamlines site operations.
Key responsibilities:
Perform administration tasks for a variety of GxP systems and associated software in a regulated (GxP) environment following defined procedures.
Defining, assigning, installing, configuring, documenting and managing user access across CTS.
Own, manage and maintain Quality records for GxP system lifecycle activities (including but not limited to user access and audit trail reviews, change management, SOP management, Events/CAPAs, Disaster Recovery and Business Continuity processes, Data Integrity assessments and implementing Data Integrity controls).
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.
Acts as liaison and interface between laboratory users, IT, OT, Engineering, Validation and external vendors in selection, implementation and lifecycle management of laboratory systems.
Act as liaison with wider business and collaborate between CTS departments on lab system activities (including but not limited to Validation, Change Management, Periodic Review, Decommissioning) for GxP computerized systems. Ensures transition of OT Systems from project to operations.
WHO YOU ARE:
Minimum Qualifications:
Bachelor of Science/IT (B.S.) or Bachelor of Arts (B.A.) degree in science or technical area.
2 years’ in a technical role supporting regulated software applications or laboratory systems
Preferred Qualifications:
Previous 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.
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
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 757 comparable Quality roles across 94 biopharma companies.
Salary context
145 of 757 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 757 comparable roles
+ 42 more countries
Seniority mix
350 of 757 peers have a known seniority level
Therapeutic area mix
1 of 757 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.