Manager, Systems & Computer Systems Validation

MedPharm • Durham, NC

5d • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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 (<300 users).
• PMP, GAMP, or equivalent certification; ITIL foundation a plus.

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).

What This Job Offers

• Job Type: Full-time
• Career Level: Manager