Direct Recruiters, Inc.
Director of Compounding Strategy & Regulatory Comp
Direct Recruiters, Inc., Cincinnati, Ohio, United States, 45208
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
,
,
. 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
,
, and
guidelines, experience in policy development, and proven leadership abilities to guide a small, high-performing team. Key Responsibilities
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. 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. 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
,
, 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.
#J-18808-Ljbffr
Director of Compounding Strategy and Regulatory Compliance
to serve as the “designated person” and subject matter expert as outlined in USP chapters of
,
,
. 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
,
, and
guidelines, experience in policy development, and proven leadership abilities to guide a small, high-performing team. Key Responsibilities
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. 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. 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
,
, 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.
#J-18808-Ljbffr