Quality & Compliance Manager – Compounding Pharmacy

As a Quality & Compliance Manager – Compounding Pharmacy you will own the quality system for our 503A compounding pharmacy, ensuring the facility is always inspection-ready and accreditation-ready. You will be responsible for authoring, maintaining, and training staff on SOPs across every facet of operations. This includes environmental monitoring and personnel qualifications to deviation/CAPA and change control. 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 <795>/<797>/<800>, state board regulations and PCAB/ACHC accreditation standards. 

• →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
• →Manage the licensure lifecycle: Class A-S, DEA registration and controlled substance recordkeeping, [nonresident licensure and the renewal calendar that comes with it]
• →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 programHost 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

• §291.133 training requirements met, with current gloved fingertip and media-fill qualification
• 5+ years in sterile compounding with real accountability for the quality system. You have been responsible for it, not adjacent to it
• Demonstrated experience designing or substantially rebuilding an EM program, including sampling rationale and action-level setting
• Track record trending microbial data, calling an excursion, and defending that call to someone who didn’t want to hear it
• Direct experience with pharmacy regulatory compliance beyond USP <797> – licensure, DEA, multistate operations
• SOP authorship and hands-on owners of a formal deviation/CAPA and change-control system
• Experience being questioned by an inspector about your records
• Strong verbal and written communication skills, with the ability to train staff clearly and build relationships with regulators, leadership, and cross-functional teams
• Well developed organizational and time management skills; comfortable managing multiple open investigations and audit preparations simultaneously

• Certified in Healthcare Compliance (CHC), RAPS RAC, ASQ CQA, or CPHQ
• CriticalPoint or ASHP sterile compounding training certificate
• PCAB (ACHC) accreditation experience, or cGMP quality-system exposure from a 503B or manufacturer
• Multistate nonresident pharmacy licensure management at scale
• Microbiology coursework or lab background — enough to argue with your contract lab productively
• USP <800> hazardous drug program build
• Experience opening a pharmacy or cleanroom from construction through first licensure
• Telehealth or mail-order pharmacy compliance background
• Active Texas pharmacist license
• Board Certified Sterile Compounding Pharmacist (BCSCP), in good standing

• Gown and enter ISO 7/8 classified areas regularly for sampling, observation, and audit 
• Extended standing and periods at a workstation and ability to lift up to 25 lb