Direct Recruiters Inc.
Director of Compounding Strategy & Regulatory Comp
Direct Recruiters Inc., Scottsdale, Arizona, us, 85261
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.
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
,
, 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.
Experience & Skills Required Experience and Qualifications:
Doctor of Pharmacy (PharmD) 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.
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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
,
, 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.
Experience & Skills Required Experience and Qualifications:
Doctor of Pharmacy (PharmD) 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.
#J-18808-Ljbffr