Job Description

The Senior Manager is accountable for IT testing activities of clinical applications including the supervision of professional level staff. The Senior Manager will provide leadership, guidance, and management services for IT testing initiatives across business units. The Senior Manager will liaise with IT Management to execute the Company\'s overall IT testing strategy by assisting in the development and coordination of computer systems validation activities. The Senior Manager will also assist and guide the career growth and development of professional level staff. The Senior Manager will be responsible for creating and implementing automated testing within the organization. The Senior Manager will work regularly with Project Managers and respective leaders from Internal Audit, Business Unit QA, IT Operations, IT Architecture, IT Global Applications and HR organizations. The Senior Manager will provide co-ordination for communication and training projects that cross multiple business units that require interdisciplinary teams to assess and manage IT testing aspects within a highly regulated environment. Provide support for internal and external computer system validation audits across business units. Responsibilities/Duties: . Implement a risked-based testing methodology for clinical applications . Identify and implement a common set of tools including test automation for conducting and executing computer systems testing that will reduce the total cost of compliance, while protecting the assets of the company. . Design and monitor performance metrics program. . Analyze and identify trends in IT performance metrics for improvement of IT initiatives. . Deliver technology, standards, and processes in accordance with department objectives and goals. . Provide training materials and co-ordinate training sessions related to computer system testing/validation topics. . Prepare validation models and test strategies for IT initiatives, and present to project teams. . Enforce Covance standard testing methodologies, procedures, and practices as they relate to systems validation. . Ensure that applications and systems are in compliance with established Covance IT standards. . Provide direction to assure that IT applications and infrastructure components possess the necessary level of testing, and required documentation to comply with applicable GxP regulations and customer requirements/expectations. Experience: . 6+ years experience leading/managing teams, developing strategies, execution of projects, 4+ years partnering/guiding clients at management levels, 4+ years leading large IT validation projects. . Familiar with various validation methodologies (SDLC), and their implementation in an IT organization . Knowledgeable of regulatory compliance requirements in the pharmaceutical and drug development industry (GxPs) . Implementing and maintaining risk based validation model & strategies . Experience with implementing automated testing strategies . Creative approach to resolving technical issues, and balancing business needs with validation requirements . Program & Project Management experience - ability to plan, organize, and execute work across multiple initiatives to drive delivery of validation commitments . IT business process development and improvement . Proven ability to build strong teams and develop professional level staff . Demonstrates self-motivation to lead teams on a unified validation strategy, while achieving department goals, objectives, and initiatives . Ability to interact with all levels within the organization . Customer relationship management . Ability to manage multiple priorities . Ability to provide leadership and training to others . Strong interpersonal skills and ability to command respect of others . Exceptional verbal, written, presentation, and interpersonal skills . Experience working with off-shore resources and contractors a plus EDUCATION/Qualifications: . 8+ years experience in a FDA (GXP) regulated industry (i.e. such as pharmaceutical, medical device, or biotechnology) . Bachelor\'s Degree required (ex. science based, operations research, technology, etc.) MS/MBA preferred. . Industry related certifications preferred (e.g. PMP, CQE, CQM, etc.) Labcorp is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our.

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