Senior GxP Quality Compliance Specialist

Supernus Pharmaceuticals, Inc.; Rockville (MD); On-site; USD 90,000 - 108,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Paid time off

401k company match

Company paid life insurance

Health and wellness benefits

Stock equity awards

Employee stock purchase programs

Discretionary annual bonus program

Job summary

Supernus Pharmaceuticals, Inc. in Rockville, MD seeks a QA professional to perform quality assurance activities, uphold GxP compliance, and support regulatory-driven audits to ensure product quality.

You will review deviations, CAPA, change controls, and SOPs while guiding supplier oversight and documentation practices. The role emphasizes adherence to FDA regulations, cross-functional collaboration, and timely QA support for clinical and bioanalytical activities.

Qualifications

• B.S. in life sciences required.
• 4+ years of GMP and/or GCP experience.
• Comprehensive understanding of GMPs, GCPs, and GLPs.

Responsibilities

• Manage internal and external GxP audits, GCP and GLP audits, and investigations as directed.
• Oversee suppliers (CMOs, distributors, labs, vendors) per management.
• Review and approve deviations, investigations, OOS, CAPA, and change controls.
• Ensure GxP records and documentation comply with FDA regs and internal standards.
• Review method validations, technical reports, stability protocols and related reports.
• Review and approve clinical and bioanalytical protocols and reports.
• Maintain QA compliance systems per US regs and internal standards.
• Draft and review SOPs for corporate QA and ensure compliance.
• Stay updated with CFR and FDA guidance to keep policies current.
• Assist in regulatory inspections and QA product releases as needed.
• Participate in meetings and cross-functional task forces to provide QA input.

Skills

GMP/GCP experience

Strong communication

Microsoft Office

Independent work

Team player

Education

B.S. in life sciences

Tools

Microsoft Office Suite

Job description

Supernus Pharmaceuticals, Inc. in Rockville, MD seeks a QA professional to perform quality assurance activities, uphold GxP compliance, and support regulatory-driven audits to ensure product quality.

You will review deviations, CAPA, change controls, and SOPs while guiding supplier oversight and documentation practices. The role emphasizes adherence to FDA regulations, cross-functional collaboration, and timely QA support for clinical and bioanalytical activities.