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IT Compliance Manager

Apply Share Job ID 1253 Category Information Technology Job Location Redwood City, CA, CA Posted Date 01/18/2019

Overview:

POSITION SUMMARY:

Genomic Health is seeking an IT Compliance Manager to provide management and direction for the IT Compliance function in operations and projects. This role will help to define, refine, audit, and enforce policies, standards, and procedures within IT, partnering with corporate quality assurance, security, , compliance and finance roles on quality systems, data privacy, security policies and strategy and SOX implementation in a rapidly evolving and expanding company and global regulatory landscape.

The position will report to the Associate Director of Security and Compliance within the Office of the CIO.

RESPONSIBILITIES / DUTIES:
· Manage IT control systems and processes to prevent or deal with violations of IT compliance guidelines and internal policies, including SOX, Quality Systems, and GHI corporate compliance training requirements for IT employees.
· Act as subject matter expert for IT quality system related procedures, deliverables, and activities
· Author, revise and, maintain IT Compliance policies, procedures, forms, and work instructions
· Conduct and report the finding of IT internal audit against all internal corporate and IT policies and procedures and external agency regulations
· Make recommendations and develop action plans for continuous quality improvement
· Manage and execute day-to-day Compliance operational tasks (e.g. SOX controls, compliance metrics reporting, internal audits, document review)
· Author Compliance, communications, presentations and training materials
· Project coordination and management for related projects and initiatives
· Ensure the conduct of or perform gap analyses, review audit results, and identify root causes to determine and implement corrective actions/preventive actions (CAPA)
· Measure and report IT Compliance performance against internal and external benchmarks and industry best practice
· Partner with Information Security to perform assessments and audits for potential IT vendors
· Other responsibilities as assigned
· Plan and implement automation improvements for our SOX processes and GRC controls.
· Evaluate the efficiency of controls and improve them continuously.
· Ensure proper accounting of SOX documentation for IT to include Risk Control, process narratives, testing, issue evaluation, and reporting.
· Prepare & maintain audit materials & regulatory compliance documentation. Collaborate with auditors, meet with examiners and implement controls as needed.
· Keep abreast of regulatory and IT compliance developments within or outside of the company as well as evolving best practices in compliance control.
QUALIFICATIONS:

REQUIRED
· 8-12 years of experience in IT in a quality and/or compliance specialist or manager role
· Work in a regulated environment (healthcare, financial, pharmaceuticals, etc.)
· Experience in at least one of the following regulatory areas: FDA 21 CFR 820, ISO 13485, SOX, HIPAA, HITECH, CLIA, CAP
· Excellent knowledge of reporting procedures and record keeping.
· BA/BS or equivalent experience
· Excellent verbal and written communication
· Detail-oriented personality, strong organizational skills
· Ability to work as part of a team

DESIRED
· Certified Information Systems Auditor (CISA) certification
· Project Management Professional (PMP) certification
· Six Sigma certification
· ISO9000 and/or SEI Capability Maturity Model Integration experience

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This role will help to define, refine, audit, and enforce policies, standards, and procedures within IT, partnering with corporate quality assurance, security, , compliance and finance roles on quality systems, data privacy, security policies and strategy and SOX implementation in a rapidly evolving and expanding company and global regulatory landscape.
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If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!