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.

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

Comp | Perks | Benefits

• Robust and affordable Medical, Dental, and Vision plan options
• Flexible time off policy

**Base 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.

What you get to do every day

• 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

What you bring to the role

• §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

Bonus points

• 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

Physical Requirements

• 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

All Company policies and procedures are subject to change without notice based on business needs. This includes, but is not limited to, the locations where we hire remote, hybrid, or onsite employees.