Director of Pharmacy Operations – 503A

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the strategic evaluation and expansion of existing 503a compounding facilities.

• Develop and implement a comprehensive multi-phase facility development strategy.

• Propel production scaling efforts by analyzing current batch sizes and staffing models.

• Supervise the application of lean manufacturing practices and continuous improvement techniques.

• Establish and track production KPIs, including batch yield and cycle time.

• Ensure operational readiness for inspections by the state Board of Pharmacy and FDA.

• Provide direction and oversight regarding state Board of Pharmacy licensure.

• Collaborate closely with Quality Assurance and Regulatory Affairs teams.

• Work in partnership with facility General Managers and production supervisors to synchronize operational priorities.

• Manage the operational profit and loss for designated 503a facilities.

• Collaborate with facility General Managers to assess and enhance the leadership team.

⛳️ Requirements

• PharmD or Bachelor's degree in Pharmacy is mandatory.

• A minimum of 4 years of direct experience in a 503a compounding pharmacy is required, with a proven track record in production operations, regulatory compliance, and/or facility management.

• Experience in a 503b outsourcing facility is a significant advantage.

• Strongly preferred is proven leadership experience in a multi-site or high-volume compounding/pharmaceutical manufacturing setting.

• Required is direct experience with state Board of Pharmacy oversight, USP / sterile and non-sterile compounding standards, as well as cGMP compliance programs; familiarity with FDA inspections is beneficial.

• A demonstrated history of leading facility development projects, capacity expansions, or production scaling initiatives is essential.

• Experience with lean manufacturing, Six Sigma, or continuous improvement methodologies is highly desirable.

• Strong financial expertise with experience in managing operational budgets, capital projects, and P&L accountability.

• Excellent communication skills and executive presence; capable of representing operations credibly to regulators, health system clients, and senior leadership.

🏝️ Benefits

• Health care insurance (medical, dental, vision).

• Life Insurance.

• Supplemental Insurance.

• Paid Time Off (PTO).

• 401K matching.

• Sick leave.