Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
- Modernized Validation Framework: 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.
- Standardized SDLC: Establish standardized Software Development Life Cycle (SDLC) requirements for all GxP systems, overseeing the full lifecycle from User Requirement Specifications (URS) and Configuration Specifications to Performance Qualification (PQ) and formal decommissioning.
- Cloud & Infrastructure Oversight: Partner with Global IT to ensure that cloud-based platforms (SaaS/PaaS) and underlying IT infrastructure are qualified and maintained in a validated state, including oversight of vendor audits and Service Level Agreements (SLAs).
- ALCOA+ Enforcement: Serve as the corporate custodian for Data Integrity, ensuring all digital records-from lab instruments to the Data Lakehouse-meet ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, and Accurate).
- Audit Trail Review Programs: Develop 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.
- Data Mapping & Risk Assessment: Lead 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.
- MasterControl Implementation: Provide technical compliance oversight for the enterprise-wide rollout of MasterControl QMS and eBatch Record (eBR), ensuring that global templates and site-specific configurations maintain a high level of regulatory rigor.
- AI & Advanced Analytics Governance: Establish the compliance framework for AI-assisted batch release and predictive modeling pilots, ensuring that "black box" algorithms are governed by the human-centric principles outlined in the EMA Reflection Paper on AI.
- Operational Technology (OT) Integration: Collaborate with MS&T and Engineering to validate the integration of shop-floor systems (e.g., Ignition MES, LIMS, PLC/SCADA) with enterprise-level data architectures.
- Change Management: Lead organizational change efforts to embed "Compliance by Design" into the company culture, ensuring that site-level personnel understand their roles as data owners.
- Global IT Alignment: Act as the primary Quality liaison to Global IT for the deployment of new technologies, ensuring that cybersecurity protocols and disaster recovery plans (including paper-based fallback procedures) meet GxP requirements.
- Site Team Support: Provide "boots-on-the-ground" assistance to site leadership during complex system deployments, helping to navigate technical hurdles while maintaining compliance standards.
- Inspection Leadership: Serve as the lead Subject Matter Expert (SME) for eCompliance and Data Integrity during regulatory inspections (FDA, MHRA, EMA, etc.), confidently defending PCI's digital validation and data governance strategies.
- Quality Metrics: Develop and monitor Key Performance Indicators (KPIs) related to system health, validation status, and data integrity compliance, using these metrics to drive proactive continuous improvement initiatives.
- External Benchmarking: Monitor the evolving international regulatory landscape (e.g., PIC/S, WHO, ISPE) to ensure PCI Pharma remains at the forefront of global eCompliance trends.
- This position may require extra hours and/or weekend work.
- Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
- Attendance to work is an essential function of this position
- Performs other duties as assigned by leadership.
Supervisory Responsibilities: Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Supervises 1-10 employees
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:- Education: Bachelor's degree in Information Technology, Computer Science, Quality Assurance, or a related scientific/technical discipline is required.
- Experience: Minimum of 10 years of progressive experience in an IT Quality, eCompliance, or Computer Systems Validation role within a GxP environment.
- Proven experience managing large-scale organizational change and digital system implementations.
- Deep technical expertise in GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and GDPR.
- Leadership: Exceptional ability to influence cross-functional stakeholders and translate complex 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 related field and/or 10+ years related experience and/or training.
- College Level Mathematical Skills
- Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
- Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
- Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
- Other Required Skills.
Preferred:- Master's Degree (M.A.) in related field and/or 5+ years related experience or training.
- Ability to work independently and/or part of a team.
- Ability to effectively present information to various people as the job requires.
- Ability to identify and resolve problems in a timely manner.
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