Director of Supplier Quality

Description

Nephron Pharmaceuticals Corporation is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron’s products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmics, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention.

As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. Nephron is currently working on research and development projects that include over 50 new products.  The company’s longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone.

Position Summary:

The Director of Supplier Quality will be responsible for overseeing and managing all aspects of vendor qualification. This position is responsible for leading the supplier quality management team to ensure the highest quality standards of materials and components supplied to company. This role focuses on developing and implementing strategies to improve supplier performance, fostering strong supplier relationships, and driving continuous improvement initiatives. 

Primary Accountabilities:

NOTE: The primary accountabilities and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager. 

· Oversee the Supplier Management (SQM) team to ensure suppliers/vendors are qualified, evaluated, and monitored in accordance with governing procedures and work instructions. 

· Design, develop, and implement strategies and processes to partner with suppliers to ensure quality and surety of supply of incoming materials.

· Implement requirements of the SQM program regarding preventative actions, qualification audits, and scorecards to measure performance.

· Perform risk assessments of current and potential new suppliers as part of the management program.

· Partner with supply chain, engineering, and operations groups to support supplier development, remediation, or improvement activities.

· Support advanced product quality initiatives for new business development.

· Ensure supplier readiness and capability for new product launches.

· Coordinate with cross functional teams to address vendor quality issues in the preliminary stages of product.

· Review, perform, or approve supplier/vendor quality alerts and/or supplier CAPAs regarding quality, issues, resolution, and performance.  

· Support and improve the Quality Management System that relate to the vendor. 

· Assist in the management of initiatives, campaigns, and special projects that are vendor related. 

· Elevate to leadership vendor issues of concern and improvement opportunities identified.

· Provide leadership to the supplier quality team to provide continuous improvement and effective supplier quality oversight and management.

· Executes supplier quality agreements across the organization, interacting frequently with senior leadership from procurement, legal, regulatory, etc.

· Salary range: Based on experience. 

· Hours of work: Monday thru Friday on an 8-hour shift, or as needed based on company demand. 

Knowledge, Skills & Abilities:

· Preferred Bachelor of Arts or Science with 10+ years of pharmaceutical or regulated industry experience or other equivalent work experience.

• 10 years in a Supplier Quality Management or related role required.

· Specific expertise, skills and knowledge within G