The Associate Director, Quality Information Systems Management, as part of the Vertex Quality Assurance Organization, is responsible for the management of the Periodic Review program and Vendor Risk Management across Vertex regulated business functions. This position will be responsible for supporting the Quality Information Systems Management (QISM) group at Vertex, working closely with the Operational functions and other QA groups to facilitate the Periodic Review program and Vendor management and oversight for technology vendors supporting Vertex.
The incumbent will have dual responsibilities of advancing the risk based Periodic Review (PR) program for GxP impacting information systems; and developing and implementing the technology vendor management (VM) program including setting up a governance structure to ensure appropriate compliance and risk mitigation.
The individual will ensure above programs and underlying activities are conducted using risk-based methodologies that assure adherence to applicable regulations, industry standards, and to Vertex policies, procedures and quality standards as set forth in the Quality Management System.
The Associate Director, Quality Information Systems Management will provide strategic, risk-based and phase-based direction to the above programs and in addition will oversee risk mitigation action plans including corrective and preventive actions. Given that both programs are companywide and impact all GxP areas, the individual will ensure comprehensive cross functional collaboration and broad-based risk and impact assessments. This individual will provide input and guidance in the development of Vertex’s Quality Management Systems and will have responsibility for managing budget, developing PR schedules and working closely with other Quality functions and stakeholders to drive/participate in vendor governance programs.
Vertex is an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. The ideal candidate is someone with experience in a broad set of technologies including cloud-based systems in multiple GxP areas.
Position may require up to 10% national/international travel.
- Periodic Review:
- Responsible for advancing risk based information systems periodic review for Vertex’s GxP operations.
- Responsible for aligning Information Systems risk based criteria with Vertex GxP operations to ensure consistency in mitigation efforts
- Lead and facilitate periodic review audit schedule development and program execution in partnership with Quality teams (Audit and Inspection Management -AIM, Quality Management Systems, Global Process Operating Center – GPOC, and Operation QA) and business leadership including GIS.
- Partner with QA leadership and business leadership including GIS leadership, for coordination and alignment in ensuring overall quality of reviews and adequacy in remediation/improvement across systems and internal operations (e.g. audit planning, review of audit outcomes, and corrective/preventive action development and implementation)
- Responsible for holistic assessment of compliance of information systems including assessment of interconnected systems and other dependencies to identify gaps and risks across entire data flow underpinning the business processes.
- Collaborate with stakeholders to develop and maintain information systems compliance metrics and report to Quality leadership Teams (QLTs) as needed.
- Vendor Management:
- Assess new and reevaluate existing vendors according to the vendor segmentation guidelines
- Establish, review, and maintain Quality Agreements with vendors
- Establish, manage, and/or participate in QA to QA forums with key suppliers, as necessary
- Triage and manage events and quality issues with vendors identified through
- review of vendor audit reports
- feedback from key stakeholders (FQA, VQM, Business, GIS, Contracting)
- Participate in audit scoping and preparation
- Collaborate with key stakeholders to develop and maintain vendor performance metrics and scorecards.
- Collaborate with AIM team to provide guidance and support for vendor audit related remediation plans.
- Collaborate across QISM to ensure alignment of risk criteria and mitigation plans.
- Key contributor to the vendor governance and management forums across various GxP areas.
- May serve as Quality Management System representative for Computer System
- Participate in collaborative review of impacted SOP/WI
- Review and analyze key Performance Indicator data and trends
- Analyze risk and propose remedial, corrective and /or preventive actions
- May participate on process improvement initiatives
- Provide cross-functional support across Vertex Quality Assurance team
- Support due-diligence and business development activities, as requested
- May coach and mentor QISM Quality Leads and GIS GxP impacting personnel to align on GxP data risks and mitigation plans.
- Partner within QISM to support Vertex inspection related activities.
- Support inspection readiness activities as needed
- Responsible for inspection management processes for information systems and engages in Preparation, Support and Follow-up activities for Inspection Readiness across GxP areas
- Supports due-diligence and business development activities, as requested
- M.S. (or equivalent degree) and 7+ years of relevant work experience, or
- B.S. in a scientific or allied health field and 10+ years of relevant Computer System/Data Integrity audit program development/maintenance and execution using risk frameworks in the regulatory compliance environment, or relevant comparable background.
In-depth knowledge in the following areas:
- Broad and deep knowledge and demonstrated experience with global regulatory requirements and standards/best practices for computer systems within GxP-regulated environments
- Demonstrated depth and breadth of global health regulatory agency knowledge and GxP experience with current knowledge of industry trends and best practices for computer systems quality, data integrity, compliance and systems controls effectiveness
- Broad and deep quality management, computer systems management, process management, project management and continuous improvement knowledge and experience
- Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence
- Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions
- Risk management principles and process, change management
- Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.
- Must be able to organize and prioritize work effectively to meet timelines with quality deliverables.
- Must be able to work independently and in a collaborative team setting.