Director of Pharmacy Operations – 503A

Emploi pas sur LinkedIn

🕒 il y a 9 jours

Postuler Maintenant

Trouver des Emplois à Distance Similaires

Configurer une alerte email pour les nouveaux emplois

📊 Vérifiez votre score de CV pour ce poste

Améliorez vos chances d'obtenir un entretien en vérifiant votre score de CV avant de postuler.

Télécharger le CV

TeleHealth

Site WebLinkedInTous les Emplois

2 - 10 employés

Fondée en 2016

🏥 Santé

Healthcare

TeleHealth est une entreprise de soins de santé (LinkedIn la classe dans la catégorie Hôpitaux et Soins de santé). TeleHealth propose des services et/ou des plateformes de télémédecine et de soins virtuels qui permettent des interactions à distance entre patients et cliniciens, des consultations à distance, et d'autres services de santé numériques.

Description

• Lead the strategic assessment and buildout of existing 503a compounding facilities, identifying gaps in infrastructure, equipment, cleanroom capacity, and workflow that limit production throughput. • Develop and execute a multi-phase facility development roadmap aligned with commercial demand forecasts, including capital project planning, equipment qualification, and process validation milestones. • Drive production scaling initiatives by evaluating current batch sizes, fill/finish capacity, formulation pipelines, and staffing models to increase output without compromising product quality or compliance. • Oversee the implementation of lean manufacturing and continuous improvement methodologies to eliminate bottlenecks and improve production efficiency across all facilities. • Partner with Engineering and Facilities teams on cleanroom upgrades, HVAC qualification, water system enhancements, and other infrastructure investments required to support higher-volume compounding operations. • Define and monitor production KPIs including batch yield, cycle time, on-time release rates, and capacity utilization; use data to drive operational decisions and report progress to the senior leadership team. • Maintain operational readiness for state Board of Pharmacy and FDA inspections across all 503a compounding facilities, ensuring site systems, documentation, and personnel practices meet or exceed USP <795>/<797> and applicable cGMP requirements. • Provide guidance and oversight on state Board of Pharmacy licensure, DEA registration, and federal statutory requirements applicable to each facility location. • Partner closely with the Quality Assurance and Regulatory Affairs functions to ensure SOPs, batch records, environmental monitoring programs, and deviation management systems are current, compliant, and effectively executed. • Champion a quality culture across all facilities through visible leadership, training investment, and accountability structures. • Lead operational response to FDA Form 483 observations, warning letters, or significant quality events, including root cause analysis, CAPA development, and effectiveness of verification.

🎯 Exigences

• PharmD or Bachelor's degree in Pharmacy required. • Minimum 4 years of direct 503a compounding pharmacy experience required, with demonstrated involvement in production operations, regulatory compliance, and/or facility management. • Experience in a 503b outsourcing facility is a strong advantage. • Proven leadership experience in a multi-site or high-volume compounding/pharmaceutical manufacturing environment strongly preferred. • Direct experience with state Board of Pharmacy oversight, USP <795>/<797> sterile and non-sterile compounding standards, and cGMP compliance programs is required; familiarity with FDA inspections is an advantage. • Demonstrated track record of leading facility development projects, capacity expansion, or production scaling initiatives. • Experience with lean manufacturing, Six Sigma, or continuous improvement methodologies is highly desirable. • Strong financial acumen with experience managing operational budgets, capital projects, and P&L accountability. • Exceptional communication and executive presence; ability to represent operations credibly to regulators, health system customers, and senior leadership.

🏖️ Avantages

• Health care insurance (medical, dental, vision) • Life Insurance • Supplemental Insurance • PTO • 401K matching • Sick leave