Senior Manager, IT Quality and Compliance

FTINC Fortrea Inc.; North Carolina; Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

Fortrea Inc. is seeking a Senior Manager, IT Quality and Compliance to lead IT audit support, risk assessment, and program management within a global quality framework. You will work with IT and business units, clients, sponsors, and inspectors to ensure timely responses and compliant documentation.

The role emphasizes cross-functional leadership, career development for staff, and alignment with statutory and industry best practices in IT quality and validation.

Qualifications

• 8+ years in audit/compliance with 5+ years IT/data management focus.
• Experience in CRO/clinical industry.
• Strong knowledge of audit processes and program management.
• Experience in heavily regulated environments (SOX or GxP).
• Familiar with regulatory requirements in pharma and drug development in USA, EU, APAC.
• Knowledgeable in validation methodologies (SDLC) in IT.

Responsabilités

• Lead internal business and IT partners in audits (client, regulatory, QA).
• Coordinate contract reviews, client questionnaires, and proposals affecting IT compliance.
• Be the point of contact for IT audit support and ensure adequate resourcing.
• Track planning and report audit support metrics for timely actions.
• Lead components of the IT Quality program globally.
• Represent IT Quality on global IT projects and governance committees.
• Guide business units on compliance with statutory requirements and ensure documentation.
• Triages IT Quality Events and ensures CAPA actions close on time.
• Recommend controls for computer systems to ensure data integrity and safety.

Connaissances

Audit experience

IT risk management

Regulatory compliance

Leadership

Client & stakeholder management

CRO/Clinical industry experience

SOX / GxP knowledge

SDLC validation

Description du poste

Reporting to the Director, Global IT Quality and Compliance (IT Q&C), the Senior Manager, IT Quality and Compliance is a member of the Global IT Quality and Compliance leadership team and responsible for assisting the Director in the execution, operational management, and performance of one or more of the disciplines of the IT global controls framework, program management, IT risk assessment, IT audit management and M&A support. The Senior Manager is the interface of Fortrea IT to our clients, customers, study sponsors and Inspectors. As in the interface, you will also work with the various IT groups to obtain answers to audit queries and to ensure proper follow-up and on-time completion to IT Quality events. The Senior Manager will also facilitate and guide the career growth and development of professional level staff.

Summary of Responsibilities

• Lead internal business and IT partners (manage IT involvement) in audits (client, regulatory, and QA).
• Coordinate, review and complete contract reviews, client questionnaires, requirements for proposals, and other compliance initiatives as they impact IT.
• Point of contact for IT audit support resources and ensure appropriate IT audit support levels.
• Tracking, planning and reporting of audit support metrics to ensure appropriate resourcing levels.
• Lead in the management and execution of one or more components of the overall IT Quality program globally.
• Represent IT Quality on global IT projects and committees serving as subject matter expert and/or provide oversight to guide business units on how to comply with statutory and develop and maintain formal documentation including policies, standards, and procedures, consistent with corporate, legal and regulatory requirements as well as industry standard best practices.
• Represent in key IT Governance teams representing IT quality interests (i.e. system validation, infrastructure controls, risk management, policy compliance, etc.).
• Triage of Audit Quality Events (QE) to ensure appropriate IT Ownership Monitoring IT QEs and CAPAs, provide guidance and work with owners to ensure appropriate and complete actions with on-time closure.
• Recommend proper controls for the Company's computer systems to ensure the reliability of applications and infrastructure, as well as the integrity of data and safety of subjects.
• Deliver technology, standards, and processes in accordance with department objectives and goals.
• Partner with Corporate, QA, and IT Client Engagement and SLC functions to assess and leverage supplier information for validation activities.
• Lead a team by providing clear articulation of direction and expectations.
• Provide coaching and support to direct reports in the creation of robust development plans to grow leadership skills that meet succession needs.
• Educate and trains IT staff, business associates, and IT Project Leads as to the IT Quality Compliance and validation methodology, and their respective responsibilities.
• Create training materials and provide training opportunities for IT Quality and Compliance and computer system validation issues across business units.

Qualifications (Minimum Required)

• 8 years experience working with in an audit/compliance function, 5 years of which focused on IT and/or Data Management.
• Must have experience working within a CRO/Clinical Industry.
• Strong knowledge of the audit process (i.e. preparation, performance, reporting, follow-up and closure) and audit program management.
• Prior experience in heavily regulated environments such as financial (SOX) or pharmaceutical (GxP) industries.
• Knowledgeable of regulatory compliance requirements in pharmaceutical and drug development industries in USA, EU and APAC.
• Familiar with various validation methodologies (SDLC) and their implementation in an IT organization.
• Experience working in a team oriented, collaborative environment.