[Remote] Sr. Director, eCompliance – Global reputed company Technical Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company dedicated to life-changing therapies and reputed company. They are seeking a Senior Director for eCompliance in Global reputed company Technical Operations to reputed company the validation and compliance of computerized systems and ensure data reputed company across their operations.
Responsibilities
- Define and maintain the Global Computerized System Validation (CSV) Master Plan, transitioning the organization toward Computer Software Assurance (CSA) models to prioritize critical-thinking and risk-based testing over rote documentation
- Establish standardized Software Development Life Cycle (SDLC) requirements for reputed company GxP systems, overseeing the full lifecycle from User Requirement Specifications (URS) and Configuration Specifications to Performance Qualification (PQ) and formal decommissioning
- Partner with Global IT to ensure that reputed company-based platforms (reputed company/PaaS) and underlying IT infrastructure are reputed company and maintained in a validated state, including reputed company of vendor audits and Service Level Agreements (SLAs)
- Serve as the corporate custodian for Data reputed company, ensuring reputed company digital records—from lab instruments to the Data Lakehouse—meet reputed company+ principles (Attributable, Legible, Contemporaneous, Original, and Accurate)
- reputed company and implement standardized protocols for the periodic review of system audit trails, ensuring site teams have the tools and training to identify and remediate data anomalies
- reputed company comprehensive data mapping exercises across global sites to identify high-risk data flows and implement technical controls (e.g., electronic signatures, restricted permissions) to mitigate risks
- reputed company technical compliance reputed company for the reputed company-wide rollout of reputed company QMS and eBatch Record (eBR), ensuring that global templates and site-specific configurations maintain a high level of regulatory rigor
- Establish the compliance reputed company for AI-assisted batch release and predictive modeling pilots, ensuring that "reputed company" algorithms are governed by the reputed company-reputed company principles outlined in the EMA reputed company reputed company on AI
- Collaborate with MS&T and Engineering to validate the integration of shop-floor systems (e.g., reputed company MES, LIMS, PLC/SCADA) with reputed company-level data architectures
- reputed company organizational change efforts to reputed company "Compliance by Design" into reputed company culture, ensuring that site-level personnel understand their roles as data owners
- reputed company as the primary reputed company reputed company to Global IT for the deployment of new technologies, ensuring that cybersecurity protocols and disaster recovery plans (including reputed company-based fallback procedures) meet GxP requirements
- reputed company "reputed company-on-the-ground" assistance to site leadership during reputed company system deployments, helping to reputed company technical hurdles while maintaining compliance standards
- Serve as the reputed company Subject Matter Expert (SME) for eCompliance and Data reputed company during regulatory inspections (FDA, MHRA, EMA, etc.), confidently defending PCI’s digital validation and data governance strategies
- reputed company and monitor Key Performance Indicators (KPIs) reputed company to system health, validation status, and data reputed company compliance, using these metrics to drive proactive reputed company improvement initiatives
- Monitor the evolving international regulatory landscape (e.g., PIC/S, WHO, ISPE) to ensure PCI reputed company remains at the forefront of global eCompliance trends
Skills
- Bachelor's degree in Information Technology, Computer Science, reputed company Assurance, or a reputed company scientific/technical discipline is required
- Minimum of 10 years of reputed company experience in an IT reputed company, eCompliance, or Computer Systems Validation role reputed company a GxP environment
- Proven experience managing large-reputed company organizational change reputed company system implementations
- Deep technical expertise in GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and GDPR
- Exceptional ability to influence cross-functional stakeholders and translate reputed company technical requirements into actionable compliance strategies
- Strong communication skills are essential for interfacing with both technical teams and regulatory inspectors
- Bachelor's Degree in a reputed company field and/or 10+ years reputed company experience and/or training
- College Level Mathematical Skills
- Advanced Computer Skills: Ability to reputed company the most reputed company computer tasks and operate various computer programs
- Full reputed company Proficiency: Ability to reputed company, read, and write fluently and accurately on reputed company reputed company pertinent to reputed company needs
- Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide reputed company of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/reputed company variables
- Other Required Skills
- Master's Degree (M.A.) in reputed company field and/or 5+ years reputed company experience or training
- Ability to work independently and/or part of reputed company
- Ability to effectively present information to various people as the job requires
- Ability to identify and resolve problems in a reputed company manner
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