DurhamRecruiter
the smart solution for Durham jobs

IT Quality Manager

Company: Covance-uscareers
Location: Durham
Posted on: September 15, 2018

Job Description:

Job Overview 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. Responsibilities:

  • 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. Education/Qualifications
    • 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. Experience
      • 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. Not ready to apply? Connect with us to join our talent community.

        Keywords: Covance-uscareers, Durham , IT Quality Manager, Executive , Durham, North Carolina

        Click here to apply!

        Didn't find what you're looking for? Search again!


        I'm looking for
        in category
        within


Other Executive Jobs


Restaurant Manager with Fast Track to GM - Start at $60k+ / year
Description: At Red Robin our Assistant Managers support and ensure that the restaurant operates within Red Robin International guidelines, while meeting/exceeding sales and profitability objectives established during (more...)
Company: Red Robin
Location: Greensboro
Posted on: 09/24/2018

Restaurant Manager
Description: If operating a restaurant is your dream career, you can make it happen at Red Lobster. br br As a Restaurant Manager, you will be responsible for leading restaurant operations with a focus on delivering (more...)
Company: Red Lobster
Location: Lynchburg
Posted on: 09/24/2018

Patient Care Manager (RN)
Description: Date Posted: 9/17/2018 Job Code: PCM Location: Regular employees - WNS City: Winston Salem State: NC Country: United States of America Category: Nursing Description Greatness awaits YOU on our Home Health (more...)
Company: Advanced Home Care (North Carolina)
Location: Winston Salem
Posted on: 09/24/2018


Medical Director Pain Management
Description: Centra Medical Group is searching for a Board Certified Medical Director to lead its Pain Managment Department. Duties Breakdown: ---90 Clinical ---10 Administrative Team Composition: ---Physicians: (more...)
Company: Centra Medical Group
Location: Lynchburg
Posted on: 09/22/2018

Sales Manager
Description: Sales Manager Now Hiring Sales Manager to sell facilities, services, and staff of the Hotel in accordance with the facilities business/marketing plans in order to meet or exceed budgeted sales department (more...)
Company: TWIN CITY QUARTER
Location: Winston Salem
Posted on: 09/22/2018

Travel Nurse (RN) - Case Manager (Case Management) - 13 Weeks
Description: This is a 13 week travel RN Nurse - Case Management Case Manager assignment in Lynchburg, VA. Don't miss this exciting Utilization Review travel Registered Nurse job opportunity At Cirrus, you can (more...)
Company: Cirrus Medical Staffing
Location: Lynchburg
Posted on: 09/24/2018

Sales Manager
Description: Sales Manager Join a powerful company with empowered associates Begin your success story here Looking for a career that combines your brilliant people skills with your enthusiasm about customer service (more...)
Company: Aaron's, Inc.
Location: Durham
Posted on: 09/22/2018

Program Director (Health Care)
Description: Title: Program Director Health Care Location: Raleigh, NC Duration: 11 Months Job Description The Program Director of Health Plan Informatics will fulfill the mission and execute the vision of the Data (more...)
Company: Serenity Infotech
Location: Raleigh
Posted on: 09/22/2018

Program Director - Health Informatics
Description: Direct End Client:State of North Carolina Job Title:Program Director - Health Informatics Duration:12 Months Start Date:10/01/2018 Location:Raleigh, NC 27604 Position Type:Contract Interview Type:In-person (more...)
Company: V Group Inc
Location: Raleigh
Posted on: 09/22/2018

Nurse Case Manager - 1+ Year Nurse Case Management REQUIRED
Description: trustaff is currently seeking an experienced Nurse Case Manager RN for a 13-week travel contract.RN Case Managers are registered nurses who develop, implement, and evaluate individualized patient care (more...)
Company: Trustaff
Location: Lynchburg
Posted on: 09/22/2018

Log In or Create An Account


Find us on Facebook

Find us on LinkedIn

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Durham RSS job feeds