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IT Compliance Specialist
2 months ago
The IT Compliance Specialist plays a vital role in our compliance framework.
This role supports both internal and external audits conducted by our pharmaceutical partners, regulatory bodies, and quality assurance teams.
As a Subject Matter Expert (SME) on Quest applications, you will assist in interpreting Federal and State Regulations.
The SME will also support Laboratory Automation and Standardization transitions for Quest Diagnostics.In your capacity as a Scrum SME, you will facilitate the shift from the traditional Quest Process Execution Waterfall Process (PEP) to an Agile methodology.
As a Digital Analyst embedded within Scrum teams, your responsibility will be to drive data-informed decision-making throughout the lifecycle of our digital products, from strategy formulation to execution and ongoing management.
Collaborating closely with product managers, developers, and various technology and business stakeholders, you will utilize your analytical skills to enhance user experiences, foster business growth, and ensure continuous improvement.
Key Responsibilities:- Serve as a primary contact for IT and assist with all internal and external audits.
- Monitor activities in assigned IT areas to ensure adherence to internal policies and procedures, including regular account and activity reviews.
- Identify compliance observations and manage remediation tasks to completion while meeting strict deadlines.
- Conduct security control tests to assess the effectiveness of activities, including Archer Sarbanes Oxley Testing (SOX).
- Manage Archer Request for Service (RFS) and Exemptions (EXC).
Collaboration and Compliance Support:
- Work in partnership with Security Compliance and Legal teams to identify and manage privacy and data protection risks, ensuring compliance with stakeholder expectations.
- Provide recommendations for enhancing compliance-related processes and procedures within the IT department, identifying opportunities for automation of security compliance controls.
- Collaborate with management, business teams, and data teams to implement effective solutions.
- Maintain a working understanding of compliance in relation to cloud-native technologies.
- Demonstrate familiarity with security control frameworks (e.g., SOX, SOC 2, ISO, NIST, etc.).
Possess knowledge of common compliance standards (HIPAA, SOX, SOC2, GxP, NIST, and/or ISO) and experience working with internal or external auditors for at least one of these standards.
Disaster Recovery and Analytics:- Manage and support Annual Disaster Recovery Exercises.
Conduct comprehensive analyses of digital data using various tools and methodologies to inform sprint planning, backlog refinement, and prioritization discussions.
Develop and maintain a backlog of analytics-related tasks and initiatives, ensuring alignment with the product roadmap and strategic objectives.
Assist in the implementation and validation of analytics tracking solutions to guarantee accurate data collection and measurement of key metrics.
Provide regular updates and reports on key performance metrics, trends, and insights to stakeholders, including product owners and senior management.
Act as a subject matter expert on digital analytics best practices, tools, and methodologies within the Scrum team, sharing knowledge and insights proactively with team members.
Qualifications:- Education: BS/BA degree in Computer Science, Information Systems, or a related field.
- Experience: Minimum 1-2 years of FDA Regulatory knowledge (Clinical Laboratory); 1-2 years of experience with Quality Management Systems (QMS) tools and IT security compliance programs; at least 2 years in an Agile framework with digital products; experience in coaching, mentoring, or training team members.
- Knowledge: Customer Experience Management, Design Thinking, Business/Digital Analysis, Agile methodologies, and essential knowledge of the healthcare or clinical lab industry; familiarity with International Standards Organization (ISO) standards (9001, 15189, 13485).
- Skills: Change management, strong analytical and critical thinking abilities, relationship-building skills, collaborative mindset, independent work ethic, and beneficial business process mapping (BPM) skills.
- Preferred Certifications: Rally, Jira, Agile, Scrum certification.
