Job Description
We are seeking a strategic, detail-oriented Director of Compounding Strategy and Regulatory Compliance to serve as the “designated person” and subject matter expert as outlined in USP chapters of <795> , <797> , <800> . Responsible for leading the development and oversight of our compounded product offerings within a high-volume, multistate mail order pharmacy serving both sterile and non-sterile markets. This individual will play a key role in shaping product strategy, ensuring regulatory compliance, and optimizing pricing structures based on evolving client needs. The ideal candidate will have deep knowledge of USP <795> , <797> , and <800> guidelines, experience in policy development, and proven leadership abilities to guide a small, high-performing team.
Key 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.
Qualifications:
- Doctor of Pharmacy (PharmD) or equivalent degree required; advanced certifications in compounding preferred.
- Minimum 7 years of experience in sterile and non-sterile compounding operations; mail order or large-scale pharmacy experience strongly 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.
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