Sterile Compounding Quality & Compliance Lead

Remedy; Houston (TX); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Health plan

Flexible time off policy

Job summary

Remedy, now part of Thirty Madison, seeks a Quality & Compliance Manager for our compounding pharmacy. You will own the quality system, author SOPs, and train staff; ensure inspection readiness and accreditation readiness. You’ll manage environmental monitoring, personnel qualifications, CAPA, change control, and audits, with deep USP/797/800 and DEA compliance in a high-stakes sterile setting. This role offers competitive pay and benefits.

Qualifications

• 5+ years in sterile compounding with quality system accountability.
• Experience building or rebuilding EM programs and sampling rationale.
• Knowledge of USP <795>/<797>/<800> and state board regulations.
• Experience with licensure, DEA, and multistate operations.
• Strong communication and training skills.

Responsibilities

• Write the quality system from scratch: SOPs, training, and document control.
• Design environmental monitoring programs with risk-based plans.
• Lead personnel qualification and data trend analysis.
• Approve facility SOPs and third-party reports; manage investigations.
• Own the 503A framework and licensure processes across states.
• Coordinate licensure and regulatory documentation for inspections.

Skills

Sterile compounding

Quality system

SOP development

Audit readiness

Regulatory compliance

Education

Pharmacy Technician certification

CHC

RAC

CPHQ

BCSCP

Tools

USP compliance

DEA registration

PCAB/ACHC

Job description

Remedy, now part of Thirty Madison, seeks a Quality & Compliance Manager for our compounding pharmacy. You will own the quality system, author SOPs, and train staff; ensure inspection readiness and accreditation readiness. You’ll manage environmental monitoring, personnel qualifications, CAPA, change control, and audits, with deep USP/797/800 and DEA compliance in a high-stakes sterile setting. This role offers competitive pay and benefits.