Vice President, Pharmacy Development

World Reach Pharma (WRP), a newly reactivated FDA-registered 503B outsourcing facility specializing in sterile and non-sterile compounded drug products, is seeking a highly experienced Vice President, Pharmacy Development. This executive will play a critical leadership role in operationalizing the facility for commercial readiness and will assume responsibility as the Pharmacist-in-Charge (PIC). The ideal candidate will bring a blend of regulatory, clinical, and operational expertise to lead WRP through pre-operational validation, licensure, and commercial scale-up.

• Serve as the designated PIC per NYS Board of Pharmacy requirements.
• Ensure all compounded products meet FDA, DEA, and state regulations.
• Supervise compliance of cleanroom operations, environmental monitoring, aseptic processing, and batch recordkeeping.
• Oversee final release of drug products, including CoA issuance and deviation logs.

• Lead efforts to obtain and maintain 503B outsourcing facility status and required licenses.
• Act as primary liaison during inspections by FDA, DEA, and NY State Board of Pharmacy.
• Prepare, review, and maintain all validation protocols and batch release documentation.

• Ensure facility layout and operations align with cGMP workflow.
• Oversee equipment calibration and cleanroom certification.
• Address issues like surveillance setup, facility cleanup, and labeling systems.

• Develop and implement SOPs for all production stages.
• Collaborate with QA and technician teams to validate workflow.
• Drive initial production readiness for nasal spray.

• Report directly to the General Manager/President.
• Hire and mentor pharmacy and QA staff.
• Align operations with corporate objectives and expansion planning.

• Licensed Pharmacist (New York State) with eligibility to serve as PIC.
• 8–10 years of experience in sterile compounding and 503B FDA-regulated environments.
• Track record managing cGMP-compliant facilities and regulatory audits.
• Knowledge of USP /, DEA protocols, and FDA 503B compliance.
• Experience in start-up or turnaround pharmaceutical operations preferred.
• Strong leadership, communication, and team-building skills.

• Obtain NY State Pharmacy and DEA Controlled Substance licenses within first 90 days.
• Pass FDA pre-operational inspections with zero major findings.
• Produce and release first commercial batch by launch target date.
• Implement SOPs, batch records, and CAPA systems within 6 months.
• Onboard full facility team aligned to validated workflow.