Covance IT Quality Manager in Durham, North Carolina
Reporting to the Global IT Quality Director, the IT Quality Manager is primarily accountable for IT audit support.
The IT Quality Manager works in close collaboration and will be required to build strong relationships with the Global IT Function, Business IT, QA, Regulatory Groups, and Internal Audit groups across the LabCorp organization.
This position requires working knowledge of information security and of IT risk management disciplines and best practices for a GxP-regulated business environment. This role is responsible for assisting in the leadership, execution (process improvement) and delivery of activities related to the support of one or more areas of compliance activities within IT controls, IT assessments, IT audit management, program management, and M&A support. This position serves as process owner of one or more areas, described above, in support of departmental objectives and goals. The IT Quality Manager must be highly knowledgeable about the business environment and must ensure that information systems are proactively maintained in a fully functional, compliant mode.
The IT Quality Manager will support audits of IT processes and systems executed by internal and external clients, as well as prepare audit metrics, creating corrective and preventative actions (CAPA), and ensuring their completion. The IT Quality Manager will be responsible for identifying and tracking trends across various audits.
Assist internal business and IT partners (manage IT involvement) in audits (client, regulatory and QA), inspections, contract security reviews, client questionnaires, requests for information and proposals, and other compliance initiatives.
Participate in the management and tracking resolution of IT audit findings and CAPA commitments
Participate in the management of the IT Supplier/Vendor/IT Self-Inspection Management program
Maintain high level of knowledge of current and emerging laws and federal and international regulatory requirements and recent enforcement actions, government audit policies, and the availability of current IT QC techniques and inform and educate business units with tailored communications.
Analyze and identify trends in IT performance metrics for improvement of IT initiatives.
Design and implement enhancements to audit support processes, and design and monitor performance metrics program.
Provide input to client Request for Information (RFI) and Request for Proposal (RFP).
Participate 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 regarding Covance’s information security and risk posture
Develop and maintain formal documentation including risk management policies, standards and procedures consistent with corporate, legal and regulatory requirements as well as industry best practices.
Bachelor's Degree or equivalent experience in Information Technology required
7+ years of experience in an FDA and MHRA (GXP) regulated industry (i.e. such as pharmaceutical, medical device, or biotechnology)Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM, etc.)
Industry related certifications preferred (e.g. PMP, CISA, CISSP, CQE, CQM, etc.)
Strong knowledge of PCI, ISO 27001, NIST, Cobit, GAMP and HIPAA desired.
BS/BA degree or equivalent higher educational certification
A minimum of 8 years’ experience working within 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 (GxPs) industries.
Knowledgeable of regulatory compliance requirements in the pharmaceutical and drug development industry in USA and UK (GxPs) desired
Experience implementing and maintain risk based validation model and strategies
Familiar with various validation methodologies (SDLC) and their implementation in an IT organization
Program and project management experience – ability to plan, organize and execute work across multiple initiatives to drive delivery of validation commitments
Exceptional verbal, written and interpersonal communication skills
Demonstrated skills in process development and improvement
Ability to interact with all levels within the organization
Proven track record managing multiple priorities to favorable outcomes
Proven experience and success with managing legal and regulatory compliance functions.
Proven experience with information security best practices.
Proven project management and organizational skills, specifically managing multiple, concurrent projects.
Proven experience with talent management.
Highly self-motivated and directed professional, with keen attention to detail.
Excellent analytical, problem-solving and decision-making abilities.
Able to effectively prioritize tasks in a high-pressure environment.
Strong customer service and solution-focused orientation.
Experience working in a team-oriented, collaborative environment.
Job Number 2018-22126
Job Category Information Technology
Position Type Full-Time
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