Compliance

• Develop and lead a high-performing team of information technology professionals; fostering a culture of collaboration and support through coaching and mentoring; successfully translating business requirements into team deliverables, individual goals, and objectives
• Collaborate with Quality Assurance, Information Technology, Legal and Compliance, Human Resources, Finance, Regulatory, Clinical, and other business functions, as well as relevant vendors, to ensure successful planning, execution, and delivery of IT compliance initiatives
• Implement the IT Risk management process and program
• Work independently to develop and execute validation protocols, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with the validation master plan and other applicable standard operating procedures (SOPs)
• Review all validation plans, perform system validation, and create validation documentation, as necessary
• Manage Application Service Providers (ASP) and Managed Service Providers (MSP) to support projects and compliance activities
• Lead vendor audits and periodic system reviews, including user account reviews
• Lead audit defense during internal or external audits or inspections
• Collaborate with stakeholders and contractors to summarize validation results in final reports
• Lead efforts to continually improve the Computer System Validation (CSV) and Computer Software Assurance (CSA) program using compliant, efficient, and risk-based approaches
• Manage the lifecycle of documents such as procedures, instructions, change control, and validation documentation within IT to ensure proper and timely review, approval, execution, and storage
• Ensure activities and deliverables comply with both company quality assurance standards and applicable government regulations, such as FDA, ISO, and CSA guidelines.

Senior Manager, IT GxP Compliance

Quality Specialist – Customer Compliance

Compliance Specialist

Compliance Officer – Advisory

Director, Ethics and Compliance Investigations

Director, US Regulatory – Global Strategic Labelling