Manager, Systems & Computer Systems Validation

Manager, Systems & Computer Systems Validation MedPharm - 2.9 Durham, NC Job Details Full-time 19 hours ago Qualifications GAMP Vendor management Pharmaceutical regulatory compliance ICH guidelines Supervising experience Bachelor's degree Release management Vendor relationship management IT Document management systems Project leadership Project stakeholder communication FDA regulations Engineering validation

Full Job Description Job Purpose:

The Manager, Systems & Computer Systems Validation (CSV) serves as MedPharm's internal owner for scientific and quality applications and for the CSV program that keeps those systems GxP-compliant. The role anchors the upcoming Waters Empower upgrade end-to-end (scope, vendor management, validation deliverables, change control, and release) and builds a sustainable operating model for lab, quality, and document systems (Empower, LIMS, ELN, QMS, EDMS, LMS). As MedPharm enters a multi-year validated-application roadmap, this person partners closely with Quality, Lab Operations, Manufacturing, and Regulatory to translate business needs into validated, well-governed systems.

Summary of Key Responsibilities:

Owns end-to-end GxP system projects — project plan, vendor coordination, server/client architecture, user access model, data migration, and CSV deliverables through go-live and post-implementation review. Serve as the IT business partner to the QA/Lab system owner and Manufactruing system owner for all GxP systems; triage enhancement requests, prioritize the backlog, and coordinate release cycles. Run MedPharm's Computer Systems Validation program aligned to

GAMP 5, 21 CFR

Part 11, Annex 11, and

MHRA/FDA

expectations — authoring and reviewing validation plans, risk assessments, URS/FS/CS, IQ/OQ/PQ protocols, traceability matrices, and summary reports. Chair or co-chair the IT/CSV change control board; review and approve changes to validated systems, including periodic review of GxP applications on the approved schedule. Manage relationships with application vendors (Waters, LIMS vendor, QMS vendor, ERP integrator) — SOWs, escalations, roadmap alignment, and service reviews. Coach and mentor the CSV Analyst and Business Systems Analyst as those roles are added; establish templates, SOPs, and training that let CSV scale without scaling headcount 1:1. Partner with the VP of IT on the validated-applications roadmap, budget inputs, and build/buy/outsource decisions; present progress to executive leadership and Quality. Support internal and external audits (FDA, MHRA, client, ISO) for all IT/CSV topics; own responses to audit findings and CAPAs in the IT domain. Collaborate with the UK IT Site Lead to ensure validated systems and processes are consistently applied across Durham (SC, EB) and Gilford (UK).

Required Qualifications and Skills:

Bachelor's degree in Computer Science, Information Systems, Life Sciences, Engineering, or a related field. 8+ years of IT experience in a GxP-regulated life sciences environment (pharma, CDMO, CRO, biotech, or medical device), with at least 3 years directly leading CSV activities. Hands-on ownership of a Waters Empower environment — architecture, upgrades, user administration, and CSV deliverables — is strongly preferred. Working knowledge of

GAMP 5, 21 CFR

Part 11, EU Annex 11, ALCOA+ data integrity principles, and ICH quality guidelines. Demonstrated experience authoring and approving validation documentation (VP, RA, URS, FS/CS, IQ/OQ/PQ, TM, VSR) across multiple system types (lab, quality, ERP, or manufacturing). Experience managing application vendors and integrators, including SOW scoping, defect triage, and release coordination. Strong written and verbal communication skills — able to translate between scientific/quality stakeholders, IT engineers, and external auditors. Comfortable operating as a hands-on manager: equal parts project leader, business analyst, and validation practitioner.

Preferred Qualifications:

Prior experience with at least two of: LabWare / STARLIMS / LabVantage, Veeva Vault QualityDocs / QMS, MasterControl, TrackWise, SAP S/4HANA or NetSuite, MES platforms. Prior experience with advanced track and trace serialization manufacturing systems (Tracelink, Optel, etc.) Familiarity with manufacturing data flows (batch records, analytical methods, stability). Experience standing up or maturing a CSV program in a growing organization (