Senior Manager, IT Quality and Compliance
Fortrea
Summary
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.
Job description
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 regulatory requirements.
- Development 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 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
- Experience working in a team oriented, collaborative environment.
Requirements
- 8 years experience in audit/compliance function
- 5 years focused on IT and/or Data Management
- Strong knowledge of audit process and audit program management
- Prior experience in heavily regulated environments (SOX or GxP)
- Knowledgeable of regulatory compliance requirements in pharmaceutical and drug development industries in USA, EU and APAC
- Familiar with validation methodologies (SDLC) and their implementation in an IT organisation
- Experience working in a team oriented, collaborative environment
Company overview
Fortrea Holdings Inc. is a leading global contract research organization (CRO) that provides comprehensive clinical development solutions to the pharmaceutical, biotechnology, and medical device industries. Headquartered in Durham, North Carolina with operations in over 90 countries, Fortrea specializes in managing all aspects of clinical trials from Phase I through IV, including clinical pharmacology and post-approval services. The company offers a wide range of services including regulatory affairs, protocol design, operational planning, patient recruitment, project management, data management, biostatistics, pharmacovigilance, and medical writing. With over 30 years of clinical research experience, Fortrea has evolved from its heritage as Covance and Labcorp into a pureplay CRO focused on delivering agile, fit-for-purpose solutions for both emerging and established life sciences companies. The company has conducted more than 5,850 clinical trials involving over 1 million subjects in the past five years, with particular expertise in oncology, central nervous system disorders, rare diseases, and cell and gene therapies.