Compliance Manager

The Compliance Manager works to ensure controls and safeguards are in place to promote adherence to applicable federal and state laws, assess risks to the organization, and maintain the security and privacy of patient and customer data.

• Coordinates internal audits, client audits, and third-party audits including SOC 2 attestation and HIPAA Risk Assessment.
• Acts as liaison and responsible party with external parties (i.e., clients and regulatory authorities) in matters relating to quality-related inspections and audits.
• Manages vendor approval process and conduct vendor audits when necessary.
• Manages client communications and expectations.
• Provides training and consultancy to company personnel on Quality Management System requirements and associated procedures (e.g., SOPs) and regulatory authority guidelines.
• Expertise in applying HIPAA regulations, including ability to perform high-level breach analysis.
• Coordinates efforts to establish and control documents, procedures, logs and records, which provide evidence of a highly effective Quality System.
• Provides ongoing assessment of quality policies and procedures against current regulations to assure readiness for client and regulatory audits.
• Identifies and tracks risks to the company through Enterprise Risk Management.
• Plans milestones, track progress, prioritize workload.
• Performs onboarding compliance training on a rotating basis with other team members.
• Evaluates the efficiency of controls and seeks continuous improvement.
• Works with other departments to support RFPs and client questionnaires.
• Solid understanding of information technology concepts, privacy, security, and Systems Development Life Cycle (SDLC).
• Ability to work with multiple stakeholders on different problems concurrently, identifying requirements and constraints, while driving consensus.
• Writes or reviews policies, procedures, manuals, reports, and forms.
• Reviews the work of colleagues when necessary to identify compliance issues and provide advice or training.
• In-depth knowledge of compliance, specialty pharmacy and/or software development standards and best practices.
• Familiarity with the review of legal agreements covering healthcare privacy and security (e.g., Business Associate Agreements, Data Use Agreements, NDAs/confidentiality agreements, quality agreements, and security agreements) preferred.

SUPERVISORY RESPONSIBILITIES:

• Direct supervision of Compliance staff.
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing; hiring; training; coaching/mentoring; planning, assigning, and directing work; appraising performance; professional development; disciplinary actions; addressing complaints; and resolving problems.