Senior Manager, IT Quality and Compliance

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Support the Director in the execution, operational management, and evaluation of the IT global controls framework, program management, IT risk assessment, IT audit management, and M&A assistance.

• Act as the liaison between Fortrea IT and stakeholders, including clients, customers, study sponsors, and inspectors.

• Collaborate with IT teams to address audit inquiries and ensure timely follow-up and completion of IT Quality events.

• Facilitate and promote the career advancement and development of professional staff.

• Lead internal business and IT partners through client, regulatory, and QA audits.

• Oversee the coordination, review, and completion of contract assessments, client surveys, proposal requirements, and other IT compliance initiatives.

• Serve as the primary contact for IT audit support resources, ensuring adequate levels of support.

• Monitor, plan, and report on audit support metrics to guarantee appropriate resource allocation.

• Direct the management and execution of components of the global IT Quality program.

• Represent IT Quality on global IT projects and committees as a subject matter expert, providing compliance oversight.

• Create and maintain formal documentation, including policies, standards, and procedures that align with corporate, legal, regulatory, and industry best-practice standards.

• Advocate for IT quality interests within key IT Governance teams, including system validation, infrastructure controls, risk management, and policy compliance.

• Manage Audit Quality Events and ensure suitable IT ownership is established.

• Oversee IT Quality Events and Corrective and Preventive Actions (CAPAs), providing guidance and ensuring timely completion of actions.

• Suggest controls for computer systems to maintain application and infrastructure reliability, data integrity, and subject safety.

• Deliver technology, standards, and processes that are in line with departmental objectives and goals.

• Collaborate with Corporate, QA, IT Client Engagement, and SLC functions to evaluate and utilize supplier information for validation activities.

• Lead a team by clearly articulating direction and expectations.

• Mentor and support direct reports in developing their leadership skills and creating development plans.

• Educate and train IT personnel, business associates, and IT Project Leads on IT Quality Compliance and validation methodologies.

• Develop training materials and provide educational opportunities regarding IT Quality, Compliance, and computer system validation across various business units.

⛳️ Requirements

• A minimum of 8 years of experience in an audit/compliance role, with at least 5 years focusing on IT and/or Data Management.

• In-depth knowledge of the audit process, encompassing preparation, execution, reporting, follow-up, and closure.

• Experience in managing audit programs.

• Previous experience in highly regulated settings such as the financial (SOX) or pharmaceutical (GxP) sectors.

• Understanding of regulatory compliance requirements in the pharmaceutical and drug development fields within the USA, EU, and APAC regions.

• Familiarity with various validation methodologies (SDLC) and their application within an IT organization.

• Proven ability to work in a collaborative, team-oriented environment.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health benefits package including medical, dental, and vision.

• Opportunities for professional development and career advancement.

• Work in a dynamic and innovative environment.