Senior REMS Compliance Auditor - Supervisor

Brief Description

The Risk Evaluation and Mitigation Strategy [REMS] Senior Auditor provides core compliance functions and project support for the REMS Stakeholder audit group. This role involves training new hires, facilitating communication between the audit team and clients, and assisting in the completion of audits. The Senior Auditor acts as a liaison with stakeholders such as healthcare settings, pharmacies, and wholesalers/distributors, reviewing audit questionnaires, examining supporting documentation, and documenting all pertinent information within project-specific applications.

Specific Job Duties

• Consistently provide effective communication to all relevant stakeholders as the primary point of contact for REMS stakeholders in healthcare settings, pharmacies, and wholesalers/distributors.
• Maintain thorough and accurate documentation of all interactions.
• Review project-specific documentation, including audit plans, procedures, and work instructions.
• Complete timely reviews of assigned audit questionnaires as per project deadlines.
• Conduct document reviews to ensure completeness, accuracy, and compliance with REMS program standards.
• Ensure timely follow-up on audit documentation deficiencies and actions as per client timelines, communicate via phone or email for outstanding documentation.
• Identify, evaluate, and address any audit findings, and articulate results to stakeholders.
• Accurately complete audit review forms to verify adherence to REMS program requirements.
• Assist in continuous quality improvement efforts with REMS Auditors.
• Formally record and report audit results, document corrective and preventive actions.
• Collaborate with REMS Auditors to share best practices.
• Complete SOP reviews and client-specific training within specified timelines consistently.
• Develop project-specific documentation such as audit plans, procedures, and work instructions.
• Provide program audit training to REMS Associate Auditors, ensure comprehensive coverage of project and soft skills.
• Maintain professional communication across all organizational levels, with clients, sponsors, and regulatory authorities.
• Manage multiple tasks and priorities according to business needs.
• Assist in reviewing audit questionnaires and supporting documentation to meet client time constraints.
• Guide audit teams in addressing audit findings and contribute to continuous quality improvement initiatives with REMS Management and Project Management.
• Conduct on-site audits as requested by clients.
• May support the Global Quality Compliance team with client and regulatory audits.

Supervisory Responsibility

Up to five (5) direct reports.

Desired Skills and Qualifications

• Bachelor's Degree preferred.
• At least three (3) years of experience in pharmacy auditing, compliance, or a related field within the pharmaceutical and/or healthcare industry.
• Strong understanding of pharmaceutical industry practices, including Risk Evaluation and Mitigation Strategies [REMS] guidelines and FDA regulatory requirements and industry standards.
• Ability to work independently without supervision.
• Strong attention to detail and analytical skills.
• Proficiency in Microsoft Office suite.
• Strong organizational and time management skills.
• Willingness to learn and adapt to new processes and regulations.
• Ability to work efficiently and prioritize tasks effectively.
• Strong problem-solving abilities.
• Adherence to ethical standards and confidentiality protocols.
• Ability to maintain composure and professionalism under pressure.
• Traveling: up to 10%