IT Senior Manager

IT Senior Manager

Labcorp Early Development Laboratories Inc. has an opening for an IT Senior Manager. This is a remote position; can work anywhere in the U.S. Approximately 20-30% domestic and international travel to support client audits, site inspections, and vendor assessments. Assist internal business and IT partners (manage IT involvement) in audits (client, regulatory, and internal), inspections, contract reviews, client questionnaires, required for information and proposals, and other compliance initiatives. Participate in 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 regarding LabCorp's quality and compliance posture. Participate in the management and tracking resolution of IT audit findings and CAPA commitments. Participate in key IT Governance teams representing IT quality interests (i.e. system validation, infrastructure controls, risk management, policy compliance, etc.). Participate in the development and maintenance of formal documentation including policies, standards and procedures, consistent with corporate, legal and regulatory requirements as well as industry standard best practices. This position supervises 5-7 IT Client Support Specialists and 1-2 IT Managers. Must possess at least a bachelor's degree in Life Sciences, Computer Systems, Technology or a related field and at least 10 years of progressive experience as an IT Quality Manager, IT Quality Analyst, Validation Analyst or Validation Engineer or related role working within an audit / compliance function. In the alternative, at least a master's degree in Life Sciences, Computer Systems, Technology or a related field and at least 8 years of experience an IT Quality Manager, IT Quality Analyst, Validation Analyst or Validation Engineer or related role working within an audit / compliance function. Must also possess the following : at least 8 years of experience with regulatory compliance requirements in the pharmaceutical and drug development industries in USA, EU and APAC; at least 5 years of experience with audit processes and audit program management; at least 5 years of experience with direct, in-person client support requirements in the pharmaceutical and drug development industry; at least 3 years of experience with the application of software development principles in the pharmaceutical and drug development industry; at least 3 years of experience with information systems infrastructure support in a pharmaceutical and drug development industry; at least 3 years of experience with the application of information security and of IT risk management principles in a pharmaceutical and drug development industry. Any person who is interested in this position may apply to the following for consideration : Send resume to labcorphold@labcorp.com and refer to Job Code MB102025. Qualified females, minorities, and special disabled veterans and other veterans are encouraged to apply.