A growing pharmaceutical company is seeking a Compliance GXP Associate Director to join their IT organization. The role requires a seasoned pharmaceutical industry professional with extensive experience in GxP Computer System Validation and a modern, risk-based CSA -Computer Software Assurance mindset. This role will span multiple regulatory domainsGxP, GDPR, PII, and SOXbut has a primary focus on GxP-regulated IT systems. The ideal candidate will bring strategic acumen in scaling validation approaches to align with system intended use and risk level, along with hands-on experience across the pharma tech stack including cloud platforms, infrastructure, AI/ML, and business-facing applications. He/she will collaborate cross-functionally within the IT organization and with departments such as Quality, R&D, CMC, Legal, HR, and Finance to ensure compliant operation of IT systems.
Key Responsibilities:
1. IT Compliance & Governance
- Maintain the Technology Compliance Framework aligned with global regulations, organizational risks, and evolving guidance and industry standards.
- Lead implementation and maintenance of IT Policy & SOPs in support of general controls and GxP processes including a modern computer validation lifecycle in collaboration with Quality.
- Collaborate with Infrastructure and CISO to enable security governance and risk management controls in mixed regulated use environment
- Implement innovative learning approaches to user community for IT compliance procedures and practices.
- Act as a liaison to for external partners to support their understanding of companies technology compliance requirements
- Audit Management focal point for internal/external audits of the IT organization
- Develop and monitor key performance indicators (KPIs) to evaluate framework effectiveness and identify improvement opportunities
2. IT Lifecycle Management
- Internal consultant for GxP validation lifecycle planning and execution for business facing applications, infrastructure, data platforms, and AI/ML with IT peers and Business Partners supporting GxP and other regulated areas
- Maintain process for System Regulatory Assessments and associated IT Inventory
- Partner with Procurement and Legal/Compliance to ensure proactive controls for software/technology onboarding and vendor management
- Collaborate with Quality for technology related investigations, non-conformance and CAPA.
- Owner/Lead the selection, implementation, and maintenance of IT Tools for SDLC/VLC processes ( e.g. Requirement & Test Management solutions such as Veeva Validation, Kneat, Helix ALM, etc,)
Salary Range - $160,000-185,000K
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- 8-10+ years of Pharmaceutical/biotech experience in leading projects from conception to completion
- In-depth knowledge of GxP regulations related to Computer System Validation/Computer Systems Assurance, and current global technology related regulations and guidance
- Hands on experience in technology and/or quality roles using modern, Risk Based Computer Validation approaches for typical technology stack (ERP, QMS, Doc Mgmt, Learning Management, Infrastructure, Clinical Trial, PV, etc
- Experience in developing validation approaches for infrastructure and cloud based Platforms.
- Experience in using and/or implementing System Development Lifecycle and testing tools ( Example: Veeva Validation, KNEAT, HP ALM, QTest, JIRA for GxP use, etc..)
- Prior experience in validation of platforms enabling emerging technology including A&/ML
- Non-Health ministry regulatory requirements background including GDPR, PII, and SOX
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.