Senior Manager, IT Quality and Compliance

Fortrea; Durham (NC); On-site; USD 120,000 - 170,000; Full time

Job summary

Fortrea is seeking a Senior Manager, IT Quality and Compliance to join the Global IT Q&C leadership team. You will assist the Director in executing and managing IT controls, risk assessment, audit management and M&A support across the organization.

You will lead audits, coordinate compliance initiatives, and guide staff growth while ensuring on-time completion of IT quality events and proper IT governance representation.

Qualifications

• 8 years experience in audit/compliance, 5 years focused on IT/Data Management.
• Experience in CRO/Clinical Industry.
• Strong knowledge of the audit process and audit program management.
• Prior experience in heavily regulated environments (SOX or GxP).
• Knowledge of regulatory requirements in pharmaceutical and drug development industries in USA, EU and APAC.
• Familiar with validation methodologies (SDLC) in an IT organization.
• Team-oriented, collaborative environment.

Responsibilities

• Lead internal business and IT partners in audits (client, regulatory, and QA).
• Coordinate contract reviews, client questionnaires, requirements for proposals, and other compliance initiatives affecting IT.
• Be the point of contact for IT audit support resources and ensure appropriate levels.
• Track, plan and report audit support metrics for resourcing.
• Lead components of the IT Quality program globally.
• Represent IT Quality on global IT projects and committees; provide oversight to guide units on compliance.
• Represent IT quality in IT Governance teams (system validation, controls, risk, policy compliance).
• Triage Audit Quality Events to ensure IT ownership.
• Monitor IT QEs and CAPAs; guide owners to complete actions on time.
• Recommend proper controls for computer systems to ensure reliability and data integrity.

Skills

Audit processes

IT compliance

Regulatory knowledge

Team leadership

Stakeholder management

Job description

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.

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