Executive Director, IT Quality & Compliance
About the Company
Innovative life sciences company providing comprehensive clinical lab & drug development services
Industry
Hospital & Health Care
Type
Public Company
Founded
1978
Employees
10,001+
Categories
About the Role
The Company is seeking an Executive Director for IT Quality and Compliance. This strategic leadership role is pivotal in driving enterprise-wide IT compliance, governance, and quality assurance across its business units. The successful candidate will be responsible for ensuring that IT systems and processes meet global regulatory requirements and internal standards, while also promoting a culture of continuous improvement, risk awareness, and operational excellence. Key responsibilities include leading the development and execution of IT quality and compliance strategies, overseeing IT governance, risk assessments, and internal controls, and managing computer system validation activities. The role also involves supporting internal and external audits, maintaining the IT Quality Management System, and collaborating with various teams to ensure cross-functional compliance. Applicants for this role at the company should have a minimum of 10 years' experience in an FDA (GXP) regulated industry, with a Bachelor's degree in a relevant field. The ideal candidate will have a proven track record of leading large IT validation projects, at least 5 years of experience in this area, and a strong background in IT quality and compliance. Preferred qualifications include industry-related certifications and an MS or MBA. The role requires expertise in validation methodologies, knowledge of regulatory compliance in the pharmaceutical and drug development industry, and experience in financial analysis and management. The candidate should possess strong interpersonal skills, the ability to build and lead teams, and a commitment to providing excellent customer service. Program and project management experience, as well as the ability to make decisions and solve problems in a high-pressure environment, are essential.
Hiring Manager Title
Vice President, IT Global Delivery
Travel Percent
10%
Functions
Director Compliance • Durham, NC, US