Quality and Compliance Project Manager

About the position

Nephron Pharmaceuticals 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, ophthalmic, 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. 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 some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust.

Responsibilities

• Develop and execute integrated strategies that help realize the organization's purpose and drives responsible growth.
• Partner with functional leads to develop integrated plans aligned with the Quality System and promotes cGMP compliance.
• Support the Quality Unit to ensure that processes comply with internal procedures and regulatory requirements.
• Create and assist with projects to continuously improve the Quality System.
• Identify resources needed and assign individual responsibilities for various projects.
• Follow procedures to ensure change control of documents, equipment/process, materials, investigations, CAPAs, and audits are initiated, recorded, and implemented.
• Provide assistance and support for an effective Quality Unit.
• Participate and conduct inspection readiness activities, serving as a Quality representative during inspections.
• Present progress reports or presentations at appropriate intervals to multiple levels in the organization to support remediation monitoring to identify process gaps, validate compliance levels, and map processes.
• Ensure project documents are complete and current, with all documentation performed as necessary.
• Maintain strict company confidentiality.
• Ensure cross-functional alignment and accountability.

Requirements

• Project Management Certification preferred
• Bachelor of Arts or Science degree with 5+ years of pharmaceutical industry experience preferred.
• 2-5 years of experience with MS Word, Excel, and PowerPoint preferred.
• 2-4 years project management and coordination experience.

Benefits

• Salary range: Based on experience
• Hours of work: 30-40 hours per week or as needed based on company demand.
• Remote work flexibility as determined by business needs.