Application Portfolio ScopePrimary ResponsibilityDomainRepresentative SystemsRegulatory ContextClinicaleTMF, CTMS, EDC (Medidata/Veeva), IRT/RTSM, Safety/Pharmacovigilance (ArgOracle), ECOA/ePROICH E6 (R2) Google Cloud Platform, 21 CFR Part 11, EU Annex 11QualityEQMS (Veeva Quality One / Master Control), LIMS, Batch Record (EBR/MBR), QMS, Deviation & CAPA, Change Control21 CFR Part 11, ICH Q10, ISO 13485, EU GMP Annex 11R&D / CMCELN (Lab Archives / Benchling), SDMS, Formulation & Stability, Assay Mgmt, Process Development Platforms, Data Lake IntegrationsGLP, 21 CFR Part 58, ICH Q8/Q9 Good To HaveExperience With Enterprise ERP Platforms Commonly Deployed In Biotech/pharma Manufacturing Environments, Including But Not Limited To
Additional Scope (Beneficial)
- 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)