Practice Area
Healthcare IT
Region
Anywhere
Location
Hybrid
Company Location
Scottsdale AZ
Position Id
48115

Director of Compounding Strategy & Regulatory Comp

Job Description
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.
Position Responsibilities:
  • 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 <795>, <797>, and <800>, 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.

Experience & Skills:
Required Experience and Qualifications:
  • Doctor of Pharmacy (PharmD) or equivalent degree required; advanced certifications in compounding preferred.
  • Deep understanding of USP <795>, <797>, and <800> 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.