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.
Key Responsibilities
Pharmacist-in-Charge (PIC) Accountability
- 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.
Regulatory, Licensing & Inspection Readiness
- 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.
Facility and Equipment Commissioning
- 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.
Commercial Launch Preparation
- Develop and implement SOPs for all production stages.
- Collaborate with QA and technician teams to validate workflow.
- Drive initial production readiness for nasal spray.
Strategic Leadership & Operational Buildout
- Report directly to the General Manager/President.
- Hire and mentor pharmacy and QA staff.
- Align operations with corporate objectives and expansion planning.
Qualifications
- 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 <797>/<800>, DEA protocols, and FDA 503B compliance.
- Experience in start-up or turnaround pharmaceutical operations preferred.
- Strong leadership, communication, and team-building skills.
Performance Measures
- 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.