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Senior Manager of Quality Systems

Company: TC Industries Of Canada Company
Location: West Columbia
Posted on: April 10, 2021

Job 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 headquarters are 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 oversight and general management of Quality Assurance Systems and associated personnel, specifically the Scientific Quality Assurance team, Quality Investigations team, and applicable Quality Specialists. Responsible for review and approval of Non-Conformance Reports (NCR), Corrective and Preventive Action (CAPA) plans, Project Records for changes/updates to Standard Operating Procedures (SOP) within the company, Microbiology and Chemistry related documents and lab investigations, and additional reports/documentation as needed. 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. Works closely with Director of Quality Systems and Director of Quality Operations to assess impact to product quality or quality processes. Consistent collaboration with all department managers to ensure that quality standards and GMP compliance are met and maintained. Provide leadership and strategic direction to quality systems personnel. Develop and monitor appropriate metrics to track quality and process improvement. Responsible for review/approval of quarterly trend reports pertaining to any quality system. Responsible for ensuring adequate Corrective and Preventive Actions result from non-conformances or deviations, when necessary. Responsible for the coaching, training, and development of the Quality Systems team. 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. Reports to Director of Quality Systems Responsible for promptly escalating events with potential product impact to Director of Quality Systems. Responsible for ensuring a high level of employee accountability and performance. Stays abreast of any and all process changes by attending departmental meetings when necessary. Perform QA authorization or approval of process-related updates/changes. Ensure timely submission of any requests by regulatory agencies. Knowledge, Skills & Abilities: Minimum or higher - Bachelor of Science degree with 5+ years of pharmaceutical manufacturing or FDA regulated industry experience. Experience with department-wide leadership. Knowledge and understanding of cGMP, FDA guidance for pharmaceutical manufacturing, USP, and other applicable regulatory guidance. Demonstrated success with process improvements to increase efficiency and effectiveness within a department. Proficient with MS Word, Excel, and PowerPoint preferred. Excellent written and Oral communication skills. Excellent public speaking and presentation skills. Must be able to interact with external customers and/or inspection auditors in a professional manner as well as all internal departments. Ability to work independently and be dependable. Technical writing skills required. 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 within Quality Assurance gained through education and experience. The ability and willingness to change direction and focus to meet shifting customer needs and business demands. 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. The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. The ability to manage a multitude of resources and to be accurate and current with data and information. Position requires standing (10%), sitting (70%), walking (20%), talking, typing and hearing. Incumbents required to wear specified protective equipment as necessary. Salary range: Based on experience Hours of work: Monday through Friday on an 8-hour shift, or as needed based on company demand. Strong attention to detail. 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, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law. Nephron Pharmaceuticals is a drug free workplace.

Keywords: TC Industries Of Canada Company, Columbia , Senior Manager of Quality Systems, Executive , West Columbia, South Carolina

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