Director, Compounding Operations - Romeoville, Illinois
On-siteRomeoville, Illinois, United States
Job Summary
Lead end-to-end compounding operations across all sites, ensuring consistent execution, operational efficiency, and full regulatory compliance. Serve as the subject matter expert for USP <795>, <797>, and <798>, maintaining continuous inspection readiness and leading internal, Board of Pharmacy, and regulatory audits. Standardize and continuously improve compounding workflows, batch records, documentation practices, policies and procedures, and training programs across all sites. Establish and enforce rigorous batch record review and verification processes across technicians, pharmacists, and Quality Assurance. Lead deviation investigations and corrective and preventive actions in partnership with the Quality team, serving as the escalation point for compounding and quality-related issues. Define, monitor, and improve key operational and quality metrics, including deviations, right-first-time performance, and throughput. Produce high-quality, data-driven reports on compounding strategy, operations, quality, and compliance. Ensure the qualification, maintenance, and ongoing compliance of compounding equipment and facilities. Collaborate cross-functionally with Quality, Compliance, Legal, and Product teams to support operational initiatives and new product introductions. Support the hiring, training, and professional development of compounding pharmacists and technicians. Build and sustain a culture of compliance, uncompromising safety, accountability, and operational excellence. Requires minimum of 5 years of experience in pharmacy compounding operations, advanced working knowledge of USP standards, and at least 2 years of leadership experience. Doctor of Pharmacy degree preferred with active, unrestricted license. Full medical, dental, and vision insurance, 401(k) match, and up to 30% travel required.
Required Qualifications
- Minimum of 5 years of experience in pharmacy compounding operations
- demonstrated expertise in both sterile and nonsterile compounding
- Advanced working knowledge of USP <795>, <797>, and <800>
- experience supporting regulatory inspections and internal and external audits
- At least 2 years of leadership experience managing pharmacists, pharmacy technicians, or compounding operations teams
- Deep, hands-on expertise in sterile and nonsterile compounding environments
- experience including workflows, equipment, documentation, and operational controls
- Demonstrated experience partnering with Quality and Compliance teams in a regulated healthcare environment
- ability to implement and sustain compounding quality and compliance standards
- Willingness and ability to travel up to 30%
Desired Qualifications
- Doctor of Pharmacy (PharmD) degree from an accredited college or school of pharmacy
- Active, unrestricted pharmacist license in good standing
- licensure in multiple states
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