The posting
The Head of Procurement & Supply Chain will oversee and direct all sourcing, procurement, and supply chain activities for Gilbert’s compounding pharmacy network. This position plays a vital role in maintaining a consistent supply of Active Pharmaceutical Ingredients (APIs), compounding materials, packaging materials, and other essential supplies needed for both 503A (patient-specific compounding) and 503B (outsourcing facility) operations. Reporting to the Director of Pharmacy Development & Operations, you’ll develop vendor partnerships, negotiate agreements, manage inventory systems, and ensure compliance with FDA, USP, and cGMP standards for efficient and compliant pharmacy operations.
Key Responsibilities
Strategic Procurement & Vendor Management
- Develop and implement comprehensive procurement strategies for APIs, excipients, and compounding materials that ensure quality, compliance, cost-effectiveness, and supply continuity.
- Establish and maintain relationships with FDA-registered API suppliers, ensuring all materials meet USP/NF standards and cGMP requirements.
- Negotiate contracts, pricing, and terms with suppliers while maintaining quality standards and regulatory compliance.
- Build redundancy in the supply chain with qualified backup vendors for critical materials.
- Manage vendor qualification, audits, and ongoing performance evaluation programs.
API & Raw Material Sourcing
- Source and procure Active Pharmaceutical Ingredients (APIs) from FDA-registered suppliers with appropriate Drug Master Files (DMFs).
- Ensure all APIs are accompanied by Certificates of Analysis (CoA) and meet compendial specifications.
- Manage procurement of excipients, preservatives, stabilizers, and other compounding ingredients.
- Coordinate with Quality Assurance on material testing and release procedures.
- Maintain current knowledge of API availability, market conditions, and alternative sources.
503A & 503B Compliance Materials
- Procure all materials necessary for regulatory compliance including environmental monitoring supplies (air sampling, surface testing), cleanroom supplies (garments, gloves, disinfectants), quality control testing materials and reference standards, sterility testing supplies and media, and endotoxin testing materials.
- Ensure all materials meet requirements for sterile and non-sterile compounding environments.
- Maintain documentation supporting regulatory inspections (FDA, state boards of pharmacy).
Equipment, Packaging & Fulfillment Materials
- Source and procure compounding equipment (balances, hoods, autoclaves, ovens, etc.) and laboratory equipment for quality testing.
- Manage procurement of facility infrastructure materials for ISO-classified cleanrooms, including HVAC filters and environmental controls.
- Procure primary packaging (vials, syringes, bottles, jars) and secondary packaging materials (boxes, labels, shipping containers) that meet FDA and USP container closure requirements.
- Coordinate with fulfillment operations on shipping supplies, cold chain packaging, and temperature monitoring devices.
Inventory & Supply Chain Management
- Develop and maintain inventory management systems for APIs, excipients, and supplies.
- Implement just-in-time and safety stock strategies balancing carrying costs with supply security.
- Monitor expiration dates and coordinate material rotation with pharmacy operations.
- Establish KPIs for inventory turnover, stock-out prevention, and cost management.
- Implement ERP or inventory management software systems.
Cross-Functional Collaboration & Team Leadership
- Partner with Quality Assurance on vendor qualification, material specifications, and CoA review.
- Collaborate with Compounding Operations to forecast material needs and prevent production delays.
- Work with Regulatory Affairs to ensure procurement practices support licensure and inspections.
- Build and lead a procurement and supply chain team; develop SOPs for all procurement activities.
- Foster a culture of compliance, quality, and continuous improvement.
Requirements
- 7+ years of progressive procurement and supply chain experience with at least 5 years in pharmaceutical manufacturing, compounding, or related healthcare industry.
- Direct experience with 503A and/or 503B compounding pharmacy operations strongly preferred.
- Deep understanding of FDA regulations for 503A and 503B compounding pharmacies, USP Chapters <795>, <797>, and <800> requirements, and cGMP for pharmaceutical manufacturing.
- Experience with API sourcing from FDA-registered suppliers and pharmaceutical raw material procurement.
- Knowledge of sterile compounding, aseptic processing, cleanroom operations, and pharmaceutical quality systems.
- Strong negotiation and contract management skills with proven vendor relationship management abilities.
- Proficiency with ERP systems, inventory management software, and procurement platforms.
- Bachelor's degree in Supply Chain Management, Business Administration, Pharmacy, or related field required.
Preferred
- Certified Professional in Supply Management (CPSM)
- Pharmacy Technician Certification (CPhT).
- Experience working within a startup or high-growth healthcare company.
- Existing relationships with API suppliers and pharmaceutical material vendors.
What Success Looks Like (First 12 Months)
- Qualified vendor network established for APIs, excipients, and all critical materials with backup suppliers in place.
- Inventory management system implemented with zero stock-outs impacting production.
- All materials sourced meet FDA, USP, and cGMP requirements with full documentation supporting regulatory inspections.
- Cost savings achieved through strategic sourcing and contract negotiations without compromising quality.
- Strong collaborative partnerships established with Quality Assurance, Operations, and Regulatory Affairs teams.
- Standardized procurement SOPs documented and team trained on compliance requirements.
Benefits
Open to discussion
