PCI Pharma Services

Controller

• Responsible for all aspects of accounting (revenue, accounts payable, accounts receivable, billing, payroll, general ledger, fixed assets, audit, etc.)
• Direct and supervise a large team of people by proactively managing and coaching the team
• Manage and deliver the monthly financial close process timely
• Oversee variance analysis and review expenses
• Participate in the ongoing development & establishment of accounting policies, procedures, and operational strategies
• Drive continuous process improvements leveraging digital technology
• Collaborate with external auditors for successful audit results

Accounting Controller

Operations

• Develop and execute a multi-year strategic roadmap for sterility assurance
• Author and maintain global quality standards for aseptic processing and sterility operations
• Establish a Global Sterility Assurance Center of Excellence
• Lead the development and technical oversight of Site-Specific Contamination Control Strategies
• Implement a stepwise bioburden reduction program for non-sterile manufacturing sites
• Establish global standards for the sterile sampling and microbiological monitoring of clean utilities
• Co-establish best practices with site Microbiology Labs
• Evaluate and implement rapid microbiological methods and automated EM data collection tools
• Standardize global programs for disinfectant efficacy testing and site-specific cleaning validation
• Design and deploy comprehensive sterility assurance education and training programs
• Train and mentor site Industrial Microbiologists
• Oversee global programs for aseptic gowning qualification and media fill design

Senior Director, Sterility Assurance – Global Quality Technical Operations

Compliance

• Define and maintain the Global Computerized System Validation (CSV) Master Plan
• Establish standardized Software Development Life Cycle (SDLC) requirements for all GxP systems
• Partner with Global IT to ensure that cloud-based platforms and underlying IT infrastructure are qualified and maintained
• Serve as the corporate custodian for Data Integrity
• Develop and implement standardized protocols for the periodic review of system audit trails
• Lead comprehensive data mapping exercises across global sites
• Provide technical compliance oversight for the enterprise-wide rollout of MasterControl QMS and eBatch Record
• Establish the compliance framework for AI-assisted batch release
• Collaborate with MS&T and Engineering to validate the integration of shop-floor systems
• Lead organizational change efforts to embed 'Compliance by Design' into the company culture
• Act as the primary Quality liaison to Global IT for the deployment of new technologies
• Provide 'boots-on-the-ground' assistance to site leadership during complex system deployments
• Serve as the lead Subject Matter Expert for eCompliance and Data Integrity during regulatory inspections
• Develop and monitor Key Performance Indicators (KPIs) related to system health, validation status, and data integrity compliance
• Monitor the evolving international regulatory landscape to ensure PCI Pharma remains at the forefront of global eCompliance trends.

Senior Director, eCompliance – Global Quality Technical Operations

Project Manager

• Engage with global stakeholders from various segments/functions
• Plan, execute, and implement scoped concurrent Projects/Programs/Portfolios
• Manage complex concurrent medium to large-scale projects
• Identify and remediate risks, issues, and scope/timeline/cost creeps
• Manage assigned Projects against cross-program/portfolio dependencies
• Drive Projects with cross-functional internal and external teams

Project Manager, ERP PMO

QA Automation Engineer

• Design and specify automated control systems.
• Maintain and troubleshoot automated control systems.
• Direct and perform installation of automation hardware and software.
• Program automated control systems to achieve the functional requirements.
• Oversee mechanical systems installation and participate in commissioning activities.
• Provide input for and author URS, FRS, SAT, IQ, OQ, PQ, and SOP documents.
• Evaluate existing systems for continuous improvement.
• Provide in-depth technical review of all documents and complete GMP documentation including change controls, data integrity assessments, deviations and CAPAs, and the closing of audit observations.
• Research new technologies and implement new/upgraded systems.
• Document changes to systems per change management procedures.
• Travel between facilities to support all functional areas.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Accounting Controller

Senior Director, Sterility Assurance – Global Quality Technical Operations

Senior Director, eCompliance – Global Quality Technical Operations

Project Manager, ERP PMO

Automation Engineer III