Apply on Employer Site

hims & hers · 1 week ago

Senior Manager, Sterile Operations

Gilbert, Arizona

Full-time

Onsite

Senior Level

5+ years exp

Hims & Hers is the leading health and wellness platform, dedicated to redefining healthcare by prioritizing customer needs. The Senior Manager, Sterile Operations will oversee sterile compounding operations, ensuring compliance with regulations while managing and training a team of pharmacy professionals.

Health CareLifestyleMen'sWellnessWomen's

Responsibilities

Serve as one of the Designated Persons for USP 797 and USP 800

Maintain and enforce proper aseptic technique and cleanroom standards

Provide training and supervision to compounding personnel including direct supervision of 8 shift managers and indirect supervision of 100+ pharmacy technicians and pharmacists

Drive daily/weekly/month performance for Safety, Quality and Financial performance metrics

Maintain training requirements to support the execution of sterile compounding including hand hygiene, gowning and media fill qualifications

Perform and accurately document compounding procedures, quality assurance/quality control checks, of compounded sterile preparations

Review and approve materials prior to use in sterile compounding

Oversee use of equipment for sterile compounding operations and monitor the compliant operation of the compounding environment in conjunction with the maintenance team

Oversee cleanroom workflow, daily logs and environmental monitoring procedures in conjunction with quality

Work closely with R&D Teams on the development and scale up of new compounded sterile preparations

Work closely with the Technical Services team to create and implement projects that result in cost savings and process improvements that elevate quality standards and throughput capabilities

Partner with quality to perform risk assessments, conduct investigations, and design and implement remediation and risk mitigation strategies

Follow all safety, USP, BOP, and internal guidelines for the preparation of compounded medications

Maintain a safety-first mindset and ensure precautions are taken in all compounding activities in accordance with USP 797 including when working with hazardous chemicals in accordance with USP <800> and applicable laws

When required, wear all personal protective equipment (PPE)

Coordinate with the Pharmacist-in-charge (PIC) for personnel, quality, compliance and regulatory matters

Willingness to complete external training as required

Qualification

Sterile CompoundingUSP 797 ComplianceUSP 800 CompliancePharmacist LicenseBoard CertificationManagerial ExperiencePharmacy Laws KnowledgeTraining SkillsAseptic TechniqueQuality AssuranceSafety ComplianceLeadershipCommunication SkillsTeam CollaborationProblem SolvingFlexibility

Required

5+ years of pharmacist experience, at least 3+ sterile compounding preferably compounding from nonsterile starting components

Board Certification in Sterile Compounding or willingness to complete in the first year of employment

Doctor of Pharmacy (Pharm D) or Bachelor's degree in Pharmacy from an accredited institution

Active Pharmacist License in State of employment (AZ)

Proficiency in USP 797 and 800 requirements and best practices

Current knowledge of state and federal pharmacy laws, rules and regulations related to the practice of pharmacy

3+ years in a managerial role over Pharmacists, Technicians, and pharmacy support personnel

Ability to work flexible shift times

Proficiency in Windows based computer systems

Must be able to undergo respirator fit testing - Full beards or a lot of facial hair may prevent a proper seal for the respirator

Must be a knowledgeable and empathetic leader to in-person pharmacist and technician teams

Must be able to lift at least 25 pounds with or without reasonable accommodation

Must be able to stand for long periods of time

Pharmacists will work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking; for prolonged periods of time

Must be able to wear required compounding safety equipment for long periods of time when required

Maintain all security and privacy rules regarding the use and handling of protected health information (PHI) in compliance with federal and state HIPAA regulations

Follow all state and pharmacy regulations and rules as designated by the required State Board of Pharmacy and the Food and Drug Administration (FDA)

Maintain a clean and sanitary work environment as mandated by the FDA's rules and regulations