Quality & Compliance Manager – Compounding Pharmacy

About the role

We are excited to join forces with Thirty Madison to revolutionize healthcare accessibility. As a Quality & Compliance Manager – Compounding Pharmacy, you will own the quality system for our 503A compounding pharmacy.

Responsibilities

• Write the quality system from scratch: SOPs and document control, training and competency, cleaning and disinfection, BUD assignment, deviation/CAPA, change control, complaints, recall
• Design the environmental monitoring program — risk-based sampling plans, alert and action levels, and the contract micro lab behind it
• Build and run personnel qualification (garbing, gloved fingertip, media fill, technique observation), then trend the data and investigate every excursion to real root cause
• Approve facility SOPs and third-party certification reports, and partner with facilities on joint excursion investigations and change control on anything touching classified space
• Own the 503A framework: bulk substance eligibility, "essentially a copy" analysis, prescriber-patient documentation, Texas office-use limits
• Qualify suppliers and outsourcing facilities, run HIPAA privacy and security with [IT/Legal], and handle adverse event, complaint, and recall processes
• Track USP revisions, TSBP rule changes, and FDA guidance in our space, and translate them into action before they're a finding — including clearing prescriber-facing materials
• Prepare the quality and regulatory content of the licensure package for the PIC's signature, and be the SME in the room when the Board inspector arrives
• Build and run the internal audit and self-inspection program
• Host TSBP, FDA, DEA, accreditation, and customer audits, and own deficiency responses and the commitments in them
• Keep the PIC and Head of Compounding current on compliance status, open investigations, and anything heading toward a reportable event

Requirements

You must have prior experience in hands-on experience building or running a quality system in a sterile compounding environment and be comfortable serving as the subject matter expert when state, federal, or accreditation auditors walk through the door. You are detail-driven, autonomous, and confident defending quality decisions and documentation under scrutiny. You also have a strong working knowledge of USP //, state board regulations and PCAB/ACHC accreditation standards.

Qualifications

• Pharmacist license is not required
• Welcome experienced pharmacy technicians (CPhT), sterile compounding professionals, and quality professionals with relevant sterile/aseptic experience

Skills

You are detail-driven, autonomous, and confident defending quality decisions and documentation under scrutiny. You also have a strong working knowledge of USP //, state board regulations and PCAB/ACHC accreditation standards.

Benefits

The base pay range for this position is $130,000 - $135,000**Robust and affordable Medical, Dental, and Vision plan options Flexible time off policyBase pay offered may vary depending on job-related knowledge, skills, and experience. An annual incentive plan and stock options may be provided as part of the compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the position offered.