Director of Compounding Strategy & Regulatory Comp

Overview

Client

Summary:

Operates an online platform for prescription medication fulfillment. Uses technology to make accessing medications simple and cost-effective. Licensed to serve customers nationwide. Offers direct-to-door delivery for convenience. Meets recognized industry accreditation standards.

• Product Strategy & Development
  • Create and maintain a robust catalog of sterile and non-sterile compounded medications tailored to client and market demands.
  • Collaborate with business development and client-facing teams to evaluate custom compounding requests.
  • Source formulations, components, and materials needed to meet formulation and regulatory requirements.
• Pricing & Cost Optimization
  • Develop competitive pricing models for compounded medications, balancing cost, quality, and margin targets.
  • Evaluate ingredient sourcing, vendor pricing, and production efficiency to optimize costs.
• Regulatory Compliance & Quality Assurance
  • Ensure all compounding activities are fully compliant with USP , , and , as well as applicable state and federal laws.
  • Oversee internal audits, gap assessments, and corrective actions related to compounding practices.
  • Coordinate appropriate testing of compounded products to confirm stability, sterility, and overall quality.
  • Maintain current knowledge of changes to compounding standards and proactively update practices accordingly.
• Policy Development & Implementation
  • Write, update, and enforce Standard Operating Procedures (SOPs) related to compounding operations.
  • Lead documentation efforts to ensure inspection readiness at all times.
  • Develop training materials to support staff understanding of new or revised compounding protocols.
• Team Leadership & Cross-functional Collaboration
  • Manage and mentor a team of compounding strategists and compliance support staff.
  • Partner with pharmacy operations, QA, procurement, and legal teams to align compounding strategy with business objectives.
  • Serve as subject matter expert (SME) for internal stakeholders regarding compounding best practices and compliance expectations.

Required Experience and Qualifications:

• Doctor of Pharmacy (Pharm
  
  D) or equivalent degree required; advanced certifications in compounding preferred.
• Deep understanding of USP , , and guidelines, with demonstrated experience implementing them in operational settings.
• Proven ability to develop and execute strategic product plans and pricing models.
• Strong leadership, organizational, and project management skills.
• Excellent written and verbal communication skills, including policy and SOP authorship.
• Experience working cross-functionally in regulated environments.

Preferred

Experience and Qualifications:

• Minimum 7 years of experience in sterile and non-sterile compounding operations; mail order or large-scale pharmacy experience strongly preferred.