Compliance Officer Compounding

Voshell's Pharmacy | Baltimore, MD (onsite) | Full-time, W-2 Pay: $95,000 to $130,000 per year, based on licensure and experience. Licensed pharmacists will be placed toward the top of the range. Benefits: health insurance, paid time off, 401(k), continuing education support

Voshell's is a Baltimore compounding pharmacy that has served patients for nearly a century. We are licensed in five states and building toward all fifty. Every new state license, every new formula, and every new prescriber relationship adds regulatory responsibility. We are looking for one person to own that responsibility end to end, so our pharmacists can focus on compounding and our leadership can grow with confidence that we are always inspection-ready.

This role is about building, not just maintaining. You will design the compliance system for a pharmacy that is growing quickly, and your voice will carry real weight when something needs more work before it launches.

Regulatory readiness. Keep us inspection-ready every day for the Maryland Board of Pharmacy, every non-resident board we hold a license with, FDA, and DEA. Run quarterly mock inspections and lead the follow-up.

USP standards. Own our program for USP (non-sterile), USP (hazardous drugs), and USP where applicable: SOP control, beyond-use dating, environmental and cleaning records, and personnel training and competency files.

503A guardrails. Oversee patient-specific prescription requirements, office-use rules by state, and FDA limits on compounding drugs that are essentially copies of commercially available products. Review new formulas and programs (GLP-1, BHRT, peptides) for regulatory risk before launch.

Multistate licensing. Partner with leadership on our 50-state licensing growth: applications, renewals, change notifications, non-resident inspection requirements, and a live license calendar.

Quality events. Own complaints, adverse events (including Med Watch reporting), errors, out-of-specification results, recalls, and corrective actions, with a clear root cause and follow-through for each.

Controlled substances and privacy. DEA recordkeeping, inventories, and CSOS oversight for Schedule III products. Ownership of our HIPAA program.

Marketing and prescriber review. Review patient-facing and prescriber-facing materials for compliant claims before they go out.

Accreditation. Lead our path to NABP accreditation.

Formula development. Develop new compounded formulas and improve existing ones: ingredient and excipient selection, compatibility and stability research, beyond-use date assignment, and master formulation records written to USP standards. Every new formula you develop is reviewed and approved by our pharmacist-in-charge before it goes into production.

Required

• 3+ years in pharmacy compliance, quality assurance, or regulatory affairs, including experience in compounding (503A or 503B), sterile or non-sterile

• Working knowledge of USP and , and FDCA section 503A

• Experience supporting a board of pharmacy or FDA inspection and leading the response

• Ability to write clear SOPs and deliver training that sticks

• Hands-on compounding formulation experience, including writing master formulation records and assigning beyond-use dates

Preferred

• Active pharmacist license (PharmD or BS Pharm), eligible for Maryland licensure

• Multistate non-resident licensing experience

• NABP/PCAB/ACHC accreditation experience

• DEA registrant compliance experience

These are the values we hire for, grow with, and hold each other to.

Integrity above all. Honesty about our work is the foundation everything else rests on. We ask that every record be accurate and every mistake be raised right away, because that is how we keep patients safe and how we earn each other's trust.

Apply…