Lead Pharmacist, Pharmacy Compliance

The role

The Lead Pharmacist, Pharmacy Compliance serves as the on-site compliance authority at a licensed compounding facility. This person will own USP compliance, manage environmental monitoring, and maintain inspection readiness.

What you will do

• Own day-to-day USP <797>, <795>, and <800> (2023) compliance.
• Manage the environmental monitoring program including sampling and tracking.
• Maintain the SOP library through drafting, updating, and training.
• Run the personnel training and competency program.
• Own the site CAPA program including deviation documentation and root cause analysis.
• Maintain facility qualification records and calibration documentation.
• Coordinate USP compliance including engineering controls and PPE protocols.
• Oversee MFR/CR completeness and supplier qualification records.
• Conduct mock inspections and support responses to state board, FDA, or accreditation surveys.
• Manage product complaints, adverse event reporting, and site-level recall procedures.

Required qualifications

• Active, unrestricted pharmacist license in the state of practice.
• B.S. in Pharmacy or Pharm.D. from an ACPE-accredited institution.
• 3+ years in compounding pharmacy operations or pharmaceutical QA at a licensed 503A facility, or 5+ years in pharmaceutical quality/compliance without direct 503A experience.
• Working knowledge of USP <797>, <795>, and <800> (2023).
• Hands-on experience with EM programs, deviation management, or CAPA systems.

Nice to have

• Additional state pharmacist licensure is beneficial
• Experience at a state-licensed 503A sterile compounding pharmacy
• Familiarity with state board inspection processes and sterile compounding enforcement
• ISO 5/7/8 cleanroom classification and NABP/PCAB accreditation experience
• Experience responding to inspection observations, FDA Form 483s, or voluntary disclosures
• Familiarity with compounding regulatory landscape

Benefits

• Medical, Dental, and Vision plans
• Flexible Spending/Health Savings Accounts
• Flexible PTO
• 401(k) + Company Match
• Life Insurance
• Pet insurance

About the company

OpenLoop provides telehealth support solutions designed to streamline care delivery for companies offering virtual support across all 50 states. The company has a relatively flat organizational structure with core values of Autonomy, Competence and Belonging.