Job Description:

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 products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. We have 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:

· Oversee all aspects of the investigations program ensuring compliance with internal procedures, industry regulations and regulatory requirements.

· Collaborate with a cross functional team to drive a culture that prevents future deviations through a robust and proactive investigation process.

· Accountable for implementation and maintenance of QMS strategy, framework, methodology, infrastructure, and procedures to ensure compliance with regulations.

· Ensure that the Quality System meets standards expected by US and other applicable global regulatory authorities for research, development, and commercial activities.

· Performs and assists with additional work duties or responsibilities as assigned or apparent.

4500 12th Street Extension, West Columbia, SC 29172 • Phone: 800.443.4313 • nephronpharm.com

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.

· Manage the investigation program in support of all NPC, 503B outsourcing, and contract manufacturing products.

· Ensure that the investigation program is in alignment with all applicable regulatory agencies for the purpose of the applicable study.

· Manage investigations in an effort for timely completion, maintaining electronic files, updating procedures as required, etc.

· Responsible to assure compliance with FDA regulations in the areas of non-conformance investigations, planned deviations, or corrective and preventive actions (CAPAs) at Nephron Pharmaceuticals Corporation.

· Partner with the Quality Management to provide leadership and guidance on investigation governance across all business functions.

· Partner effectively with other functional leaders and site Managers to develop and maintain a meaningful and robust Quality culture across all aspects of the business.

· Work collaboratively with quality investigations team with attention to repeated occurrences of similar root causes.

· Engages with site teams to review Quality Performance metrics and recommend actions for continuous improvement

· Design, implement and maintain GMP QA and QC programs related compliance infrastructure, including SOPs, training systems, and activities.

· Assess functional and organizational competencies, address gaps, plan and implement solutions.

· Manage the investigation program in support of all NPC, 503B outsourcing, and contract manufacturing products.

· Ensure that the investigation program is in alignment with all applicable regulatory agencies for the purpose of the applicable study.

· Ensure all regulatory commitments are adhered to and be proactive with regulatory and industry changes.

· Manage investigations in an effort for timely completion, maintaining electronic files, updating procedures as required, etc.

· Responsible to assure compliance with FDA regulations in the areas of non-conformance investigations, planned deviations, or corrective and preventive actions (CAPAs) at Nephron Pharmaceuticals Corporation.

· Partner with the Quality Management to provide leadership and guidance on investigation governance across all business functions.

· Partner effectively with other functional leaders and site Managers to develop and maintain a meaningful and robust Quality culture across all aspects of the business.

· Work collaboratively with quality investigations team with attention to repeated occurrences of similar root causes.

· Engages with site teams to review Quality Performance metrics and recommend actions for continuous improvement

· Assure hiring decisions and quality of hires address QA strategic and functional needs of the company; advocates for resources when needed.

· Mentor and develop competencies of QA team members.

· Facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, work with the team to analyze data across product areas to identify signals and trends and will then develop and implement appropriate process improvement strategies.

· Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management.

· Develop, analyze, and report quality metrics (e.g., key quality performance metrics) and highlights regarding Quality function.

· Assesses and provides input to strengthen company programs/strategies with an aim to increase Inspection Readiness.

· Work with colleagues to instill a sense of ownership and commitment to quality.

· Optimize the QA work of the team by helping to guide and strategize day-to-day tasks.

· Provide technical support to the leadership team in the decision-making process.

· Salary range: Based on experience.

Knowledge, Skills & Abilities:

· Bachelor of Arts or Science degree with 15+ years of pharmaceutical or FDA regulated industry experience (Director level)

· Comprehensive knowledge of quality system requirements such as US FDA GMP, GCP, EMA, and ICH guidelines and has a proven track record of successfully implementing these requirements to ensure patient safety and compliance with FDA and other applicable health authorities' requirements.

· 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 within Quality Assurance gained through education and experience.

· A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.

· The ability to take strategic objectives and accept accountability to drive results through effective actions.

· The ability and willingness to change direction and focus to meet shifting organizational and business demands.

· The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business.

· The ability to create 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 lifting (up to 40 lbs.), vision (20/20), standing (10%), sitting (40%), walking (50%), talking, typing and hearing

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.

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