Quality and Compliance Project Manager

Description

Corporate Statement:

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.

Job Purpose:  

Quality and Compliance Project Managers primary job purpose is to lead and execute projects that support the quality, compliance and operations, by developing and implementing processes, monitoring activities, and mitigating risks to maintain operational integrity and prevent regulatory issues. They have a role in maintaining the documentation to support the project and tracking in a way that can be evaluated as needed. 

Essential Duties and Responsibilities: 

• Expected to 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.

· Identifies resources needed and assigns 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. 

· Ensures project documents are complete and current, with all documentation performed as necessary.

• Maintain strict company confidentiality. 
• Team player with the highest of personal values and ethical standards. 
• Ensures cross-functional alignment and accountability.  
• Salary range: Based on experience
• Hours of work: 30-40 hours per week or as needed based on company demand. 
• This position allows for remote work flexibility as determined by business needs. 

Supplemental Functions: 

• Performs other similar duties as required.

Job Specifications and Qualifications:  

• Project Management Certification preferred 

Knowledge & Skills:  

• Excellent written and oral communication skills.
• Team player and must be able to interact with all departments.
• Ability to work independently and be dependable.
• Ability to manage, train, motivate, and discipline employees.
• Technical writing skills required.
• Strong attention to detail. 
• Incumbents are required to wear specified protective equipment as necessary.
• The ability to identify work elements in detail, and develop work standards, and work method improvements; develop procedures,      and forms to effect method improvement and work simplification.
• Specific expertise, skills, and knowledge of project management gained through education and experience.
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