Senior Manager, IT Quality and Compliance

Fortrea; Clayton (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

Fortrea is seeking a Sr. Manager of IT Quality and Compliance to drive execution and performance of IT controls, risk assessment, audit management, and M&A support.

The role interfaces Fortrea IT with clients, study sponsors, inspectors, and internal IT groups to ensure on-time audits and compliance across global projects. The successful candidate will lead audits, coordinate reviews, develop formal documentation, and represent IT Quality on global IT projects and governance committees.

Qualifications

• 8+ years in an audit/compliance function, with a focus on IT/audit disciplines.

Responsibilities

• Lead internal IT audit activities and coordinate with clients, sponsors and Inspectors.
• Coordinate contract reviews, client questionnaires, and requirements for proposals affecting IT compliance.
• Act as point of contact for IT audit support resources and ensure timely responses to audit queries.

Skills

Audit process knowledge

Audit program management

SOX / GxP experience

Regulatory compliance knowledge

Validation methodologies (SDLC)

Job description

Reporting to the Director, Global IT Quality and Compliance (IT Q&C), the Sr. 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 Sr 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. 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

Tracking, planning and reporting of audit support metrics to ensure appropriate resourcing

Lead in the management and execution of one or more components of the overall IT Quality

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

Development and maintain formal documentation including policies, standards, and

procedures, consistent with corporate, legal and regulatory requirements as well as industry

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

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.

Partner with Corporate, QA, and IT Client Engagement and SLC functions to assess and leverage supplier information for validation activities.

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.

8 experience working with in an audit/compliance function, 5 of which focused on ~ IT and/or Data Management.

• 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 organisation