About this opportunity
Location: Farmingdale, NY
Overview
The Director of RA/QA will manage the regulatory compliance and quality management systems (QMS) for global import and distribution business. The ideal candidate will oversee compliance for Rx, OTC, and Animal Health (Veterinary) Active Pharmaceutical Ingredients (APIs), as well as food/dietary ingredients.
Responsibilities include the management of a complex supply chain involving manufacturers worldwide, as well as a proprietary fulfillment facility, and an extensive network of third-party logistics (3PL) warehouses, ensuring flawless execution of FDA, USDA, and international regulations.
Responsibilities
Overview
The Director of RA/QA will manage the regulatory compliance and quality management systems (QMS) for global import and distribution business. The ideal candidate will oversee compliance for Rx, OTC, and Animal Health (Veterinary) Active Pharmaceutical Ingredients (APIs), as well as food/dietary ingredients.
Responsibilities include the management of a complex supply chain involving manufacturers worldwide, as well as a proprietary fulfillment facility, and an extensive network of third-party logistics (3PL) warehouses, ensuring flawless execution of FDA, USDA, and international regulations.
Responsibilities
- Lead FDA Strategy: Act as the primary point of contact for the US FDA, USDA, EPA, and state boards of pharmacy; spearhead all facility registrations, product listings, and regulatory submissions.
- Import/Export Compliance: Oversee foreign supplier verification programs (FSVP), import alerts, customs clearance regulatory hold resolutions, and international distribution compliance.
- GxF Compliance: Ensure absolute adherence to cGMP
- 21 CFR Parts 210/211 for pharma
- Part 507 for animal food
- Part 110/111/117 for food/supplements (FSMA)
- GFSI & BRCGS Standards
- Supplier Qualification: Oversee a robust auditing program for manufacturers across China and India, ensuring their processes meet stringent US and global standards.
- Technical Agreements: Negotiate and execute rigorous Quality Agreements with international manufacturers and active vendors.
- Internal Warehouse Oversight: Serve as the final authority on quality systems within the company-owned warehouse (including environmental controls, sanitation, and inventory segregation).
- Obtain and Maintain GFSI certification, documentation and policies.
- 3PL Network Governance: Establish QA KPIs and audit protocols for all 3PL warehouse partners to ensure proper storage, handling, and pedigree tracking of pharma and animal health ingredients.
- Chain of Custody: Implement and audit rigorous Drug Supply Chain Security Act (DSCSA) tracking and pedigree requirements for Rx ingredients.
- Quality Management: Implement a Quality Management System (QMS) for tracking corporate quality and corporate initiatives such as:
- Document Control Supplier Qualification
- Training Audit Management
- Customer Complaints Risk Management
- Deviations CAPA
- Change Control Out of Specification
- Recall Readiness: Maintain and simulate mock-recall protocols to ensure rapid execution if a product safety issue arises.
- Degree: Bachelor’s degree in chemistry, Pharmacy, Biology, or a related scientific discipline (Master’s, PharmD, or Ph.D. highly preferred).
- Experience:10+ years of progressive QA/RA leadership experience in pharmaceutical/ingredient importing, distribution, or manufacturing.
- Scale: Proven experience working within large organizations.
- Sourcing: Direct experience managing and auditing suppliers in China and India.
- Experience in implementing and managing electronic Quality Management Systems (QMS) and ERP quality systems.
- Deep expertise in FDA regulations spanning Rx APIs, OTC drug components, and Veterinary/Animal Health compliance.
- Thorough understanding of supply chain logistics, including 3PL integration and DSCSA track-and-trace systems.
- Exceptional leadership capabilities with experience managing cross-functional, remote, or international teams.
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