Senior REMS Compliance Auditor - Remote Leadership

UBC; United States; Remote; USD 110,000 - 140,000; Full time

Benefits offered by this job

Remote opportunities

Growth opportunities for promotion

401K with company match*

Flexible work environment

Discretionary PTO(Paid Time Off)

Paid Holidays

Employee assistance programs

Medical, Dental, and vision coverage

HSA/FSA

Wellness program

Adoption assistance

Short term disability

Long term disability

Life insurance

Job summary

UBC is seeking a Senior REMS Compliance Auditor with supervisory responsibilities to oversee REMS auditors, ensure audit quality, and maintain compliance with REMS program standards. The role requires training new hires, coordinating with clients, and liaising with stakeholders across healthcare settings, pharmacies, and distributors.

The Senior Auditor will lead audit activities, develop project documentation, and support continuous improvement initiatives while ensuring timely completion of

Qualifications

• Bachelor’s degree or higher preferred.
• Experience in pharmacy auditing, compliance, or related field.
• Strong understanding of REMS guidelines and FDA requirements.

Responsibilities

• Provide primary point of contact communication for REMS stakeholders.
• Maintain thorough documentation of all interactions.
• Review project-specific documentation including audit plans and work instructions.
• Complete timely reviews of audit questionnaires per project deadlines.
• Conduct document reviews for accuracy and compliance with REMS standards.
• Address audit findings and communicate corrective actions.
• Record audit results and support continuous quality improvement.
• Conduct on-site audits as requested by clients.

Skills

REMS knowledge

FDA regulatory requirements

Audit/testing

Education

Bachelor’s Degree preferred

Job description

UBC is seeking a Senior REMS Compliance Auditor with supervisory responsibilities to oversee REMS auditors, ensure audit quality, and maintain compliance with REMS program standards. The role requires training new hires, coordinating with clients, and liaising with stakeholders across healthcare settings, pharmacies, and distributors.

The Senior Auditor will lead audit activities, develop project documentation, and support continuous improvement initiatives while ensuring timely completion of