Director Of Quality Systems

Corporate Statement

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 Cheadquartered in West Columbia, South Carolina, with additional distribution centers in Kentucky and Arizona. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectable, 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:

• Responsible for all Quality Assurance systems and the implementation of corporate policies and procedures.
• Responsible for determining product/lot disposition upon conclusion of any manufacturing or laboratory investigation.
• Responsible for ensuring adequate Corrective and Preventive Actions from non-conformances or deviations, when necessary.
• Provide leadership and strategic direction to all quality systems personnel and management.
• Assess impact to product quality or quality processes.
• Develop and monitor appropriate metrics to track quality and process improvements.
• Consistent collaboration with all department heads to ensure that quality standards and GMP compliance are met and maintained.
• Ensures internal processes and metrics are aligned to create a high level of product quality and consistency, in accordance with all internal and external regulations.
• Responsible for the coaching, training, and development of the Quality Systems team.
• Responsible for review/approval of quarterly trend reports pertaining to any quality system.
• Promote Quality by Design throughout all manufacturing processes.

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.

• Stays abreast of any and all process changes by attending departmental meetings when necessary.
• General oversight of all quality systems, including but not limited to: Quality Investigations, Drug Product Quality Complaints, Scientific Quality Assurance, Quality Specialists, Change Management, Batch Release, and Continuous Improvement.
• Manage and foster a positive relationship with external contract customers focusing on Quality.
• Perform QA authorization or approval of process-related updates/changes.
• Ensure timely submission of any requests by regulatory agencies.
• Notify Chief Executive Officer and Head of Quality of major quality concerns or Quality decisions regarding batch/lot disposition.

Knowledge, Skills & Abilities:

• Excellent public speaking and presentation skills.
• The ability and willingness to change direction and focus to meet shifting customer needs and business demands.
• Incumbents required to wear specified protective equipment as necessary.
• Experience with department-wide leadership.
• Strong attention to detail.
• 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.
• Must be able to interact with external customers and/or inspection auditors in a professional manner as well as all internal departments.
• The ability to manage a multitude of resources and to be accurate and current with data and information.
• Hours of work: Monday through Friday on an 8-hour shift, or as needed based on company demand.
• Salary range: Based on experience
• Minimum or higher - Bachelor of Arts or Science degree with 5+ years of pharmaceutical or FDA regulated industry experience.
• Position requires standing (10%), sitting (70%), walking (20%), talking, typing and hearing.
• Specific expertise, skills, and knowledge within Quality Assurance gained through education and experience.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• Excellent written and Oral communication skills.
• Technical writing skills required.
• The ability to promote and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• Proficient with MS Word, Excel, and PowerPoint preferred.
• Knowledge and understanding of cGMP, FDA guidance for pharmaceutical manufacturing, USP, and other applicable regulatory guidance.
• Ability to work independently and be dependable.
• Demonstrated success with process improvements to increase efficiency and effectiveness within a department.

EEO Statement:

Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.