Compare your current skills to what this opportunity needs—we'll show you what you already have and what could strengthen your application.
Job Description
Application Portfolio Scope Primary Responsibility Domain Representative Systems Regulatory Context Clinical e
TMF, CTMS, EDC
(Medidata/Veeva), IRT/RTSM, Safety/Pharmacovigilance (ArgOracle), eCOA/ePRO ICH E6 (R2) Google Cloud Platform, 21 CFR Part 11, EU Annex 11 Quality EQMS (Veeva Quality One / Master Control), LIMS, Batch Record (EBR/MBR), QMS, Deviation & CAPA, Change Control 21 CFR Part 11, ICH
Q10, ISO 13485, EU GMP
Annex 11 R
D / CMC ELN
(Lab Archives / Benchling), SDMS, Formulation & Stability, Assay Mgmt, Process Development platforms, Data Lake integrations
GLP, 21 CFR
Part 58, ICH Q8/Q9 Good to Have Experience with enterprise ERP platforms commonly deployed in biotech/pharma manufacturing environments, including but not limited to: SAP S/4HANA or ECC (PP/PI, QM, PM, MM modules) with GMP-validated configuration Oracle Cloud ERP, NetSuite, or Microsoft Dynamics 365 in a regulated manufacturing context ERP-LIMS and ERP-MES integration patterns for batch release workflows Material master governance, BOM management, and lot/serial traceability for ATMPs or biologics Additional Scope (Beneficial) Exposure to the following corporate application domains is a plus. These systems are managed in collaboration with HR, Finance, and Legal stakeholders: People & Culture (P&C): Workday HCM, ADP, Lattice, Culture Amp, learning management systems (LMS) HRMS /
Payroll:
Workday Payroll, Rippling, or equivalent platforms; SOX-relevant access controls
Legal & Compliance:
Contract lifecycle management (Ironclad, Conga), IP management, board portals
Finance Apps:
Workday Financials, Coupa, Concur; familiarity with SOX ITcontrols Key Responsibilities Strategy & Portfolio Governance Own the enterprise application roadmap aligned to clinical program milestones, manufacturing scale-up, and regulatory filings (IND, BLA, MAA) Define and maintain the application portfolio architecture, rationalizing redundant systems and managing total cost of ownership Partner with the VP/CIO and functional leaders to translate business strategy into technology investment decisions Establish and chair an Application Governance Council with stakeholder representatives from Clinical, Quality, R D, and Manufacturing GxP Systems & Validation Serve as the senior IT accountability owner for all validated systems; ensure compliance with 21 CFR Part 11, EU Annex 11, ICH guidelines, and applicable GxP requirements Lead computerized system validation (CSV) and computer software assurance (CSA) programs across the validated application estate Oversee data integrity controls (audit trails, electronic signatures, access management) across Clinical, Quality, LIMS, and EBR/MBR systems Maintain inspection readiness; serve as senior IT liaison during FDA, EMA, or Notified Body audits and due-diligence reviews Drive the transition from traditional CSV to risk-based CSA approaches in alignment with FDA guidance Implementation & Delivery Lead end-to-end selection, implementation, and go-live of enterprise applications on time, within budget, and fully validated Manage a portfolio of concurrent projects across Clinical, Quality, and R D domains using structured project management disciplines Oversee systems integrators, SaaS vendors, and implementation partners; negotiate contracts and ensure SLA adherence Drive adoption through structured change management, super-user programs, and training in partnership with functional stakeholders Team Leadership & Operating Model Build, mentor, and retain a team of application managers, business analysts, and validation specialists across clinical, quality, and R D domains Define clear ownership and RACI for every application in the portfolio, including vendor-managed and cloud-hosted systems Establish managed services models for application support; define incident, change, and release management processes Foster a culture of continuous improvement, regulatory awareness, and cross-functional partnership Data, Security & Architecture Standards Partner with Data & Analytics on master data governance, clinical data standards (
CDISC:
CDASH, SDTM, ADaM), and FAIR data principles Enforce application security standards, role-based access controls, and separation of duties in alignment with Cybersecurity and Compliance policies Contribute to enterprise architecture decisions, API integration strategy, and cloud platform standards (AWS, Azure, Google Cloud Platform)
