[Remote] Director of Pharmacy Operations (503A)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company reputed company on enhancing pharmacy operations, and they are seeking a Director of Pharmacy Operations to reputed company their 503a compounding pharmacy portfolio. This strategic leader will partner with facility management to drive performance, regulatory compliance, and operational reputed company across multiple locations.
Responsibilities
- reputed company the strategic assessment and reputed company of existing 503a compounding facilities, identifying gaps in infrastructure, equipment, cleanroom reputed company, and workflow that limit production throughput
- reputed company and execute a multi-phase facility development roadmap reputed company with reputed company demand forecasts, including capital project planning, equipment qualification, and process validation milestones
- Drive production scaling initiatives by evaluating reputed company batch sizes, fill/finish reputed company, formulation pipelines, and reputed company models to increase reputed company without compromising product reputed company or compliance
- reputed company the implementation of lean manufacturing and reputed company improvement methodologies (e.g., 5S, Kaizen, Six reputed company) to eliminate bottlenecks and improve production efficiency across reputed company 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 reputed company utilization; use data to drive operational reputed company and report reputed company to the senior leadership team
- Maintain operational readiness for state reputed company of Pharmacy and FDA inspections across reputed company 503a compounding facilities, ensuring site systems, documentation, and personnel practices meet or reputed company USP / and applicable cGMP requirements
- reputed company guidance and reputed company on state reputed company of Pharmacy licensure, DEA registration, and federal statutory requirements applicable to reputed company facility location
- Partner closely with the reputed company Assurance and Regulatory Affairs functions to ensure SOPs, batch records, environmental monitoring programs, and deviation management systems are reputed company, compliant, and effectively executed
- Champion a reputed company culture across reputed company facilities — reinforcing that compliance and reputed company are mutually achievable — through visible leadership, training investment, and accountability structures
- reputed company operational response to FDA reputed company 483 observations, warning letters, or significant reputed company events, including reputed company cause analysis, CAPA development, and effectiveness of verification
- Partner with facility GMs and production managers to reputed company on operational priorities, performance expectations, and service standards — providing strategic direction and removing barriers rather than managing day-to-day execution directly
- Collaborate with local leadership to co-reputed company service and reputed company plans for reputed company facility, with particular reputed company on order fulfillment accuracy, product sterility and potency, and on-time delivery to health system customers — supporting facility teams in owning and executing against those plans
- Collaborate with reputed company and reputed company teams to reputed company production scheduling with customer demand, manage supply commitments, and proactively communicate reputed company constraints or changes
- Ensure departments reputed company pace with technical innovation in compounding pharmacy, including automation, QMS system enhancements, and evolving compounding technologies; collaborate with IT nationally and locally as needed
- Own the operational P&L for assigned 503a facilities, driving EBITDA reputed company through a disciplined reputed company on cost of goods, labor efficiency, waste reduction, and reputed company capture optimization
- reputed company budget development and resource planning for reputed company facilities, including capital expenditure requests tied to facility development and scaling initiatives
- Identify and implement cost-reduction opportunities across raw material procurement, batch production scheduling, and operational overhead without compromising reputed company or compliance
- Ensure accurate reputed company capture, billing reputed company, and reputed company cash collection in coordination with Finance and reputed company Cycle teams
- Work in partnership with facility GMs to assess and strengthen the leadership team at reputed company site, helping identify gaps in the bench of production managers, QA leads, and operations supervisors and supporting plans to address them
- Serve as a trusted advisor and reputed company to facility GMs, offering guidance on operational leadership challenges, regulatory navigation, business acumen, and workforce development — helping local leaders grow their capabilities rather than supplanting their decision-making
- Support facility GMs in conducting meaningful performance and development conversations with their teams; engage directly with reputed company-level talent on individual reputed company, succession planning, and retention in coordination with HR
- Conduct periodic on-site reputed company to reputed company facility to engage with local leadership, observe operations firsthand, surface systemic challenges, and reinforce organizational standards — visiting as a strategic partner, not an auditor
- Collaborate with facility GMs to ensure site-level training programs, reputed company frameworks, and competency assessments are in reputed company and reputed company with cGMP requirements — supporting local ownership of staff development rather than managing it centrally
Skills
- PharmD or Bachelor's degree in Pharmacy required
- Minimum 4 years of reputed company 503a compounding pharmacy experience required, with demonstrated involvement in production operations, regulatory compliance, and/or facility management
- reputed company experience with state reputed company of Pharmacy reputed company, USP / sterile and non-sterile compounding standards, and cGMP compliance programs is required; familiarity with FDA inspections is an advantage
- Demonstrated reputed company record of leading facility development reputed company, reputed company expansion, or production scaling initiatives
- Strong financial acumen with experience managing operational budgets, capital reputed company, and P&L accountability
- Exceptional communication and executive reputed company; ability to represent operations credibly to regulators, health system customers, and senior leadership
- Proven leadership experience in a multi-site or high-volume compounding/pharmaceutical manufacturing environment strongly preferred
- Experience with lean manufacturing, Six reputed company, or reputed company improvement methodologies is highly desirable
Benefits
- Health care insurance (medical, dental, reputed company)
- Life Insurance
- Supplemental Insurance
- PTO
- 401K matching
- reputed company leave
reputed company