QA: Senior Manager Change Control

Description

Job Title: QA: Senior Manager Change Control 

Reports To: Director of Document and Change Control

FLSA Status: Exempt

Company:  Nephron SC, LLC 

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: 

The purpose of Change Control Manager is to oversee compliance with FDA regulations in the areas of document, process, facility, material and equipment changes, along with validations, qualifications and calibrations at Nephron Pharmaceuticals Corporation. Provide guidance and expertise on change control and document review practices to team members. Ensure proposed changes to products, processes, or systems maintain quality and compliance by evaluating the impact of changes and implementing necessary controls. Act as a technical resource for the business units to ensure awareness of the impact of a change.

Essential Duties and Responsibilities:

• Facilitate review and approval of change records, calibration records, maintenance records, validation protocols, stability protocols and work orders.
• Evaluate proposed changes to manufacturing processes, products, equipment, and facilities to assess their potential impact on product quality and compliance. 
• Ensure all changes are properly documented, including change requests, change assessments, and action plans. Ensure that all changes comply with relevant quality standards, regulations, and company policies.
• Participate as a SME in the investigation review and approval process.
• Review documents for authorization and approval of required or needed changes and ensure correctness and completeness.
• Hold Change Review Board meetings and present KPIs for change controls during CRB meetings. 
• Present quarterly trend and KPI data at Quality Management Review meetings. 
• Assist in the management of initiatives, campaigns and special projects.
• Review revision of controlled documents and labels to ensure compliance with the regulatory submissions and requirements.
• Ensure data integrity and accuracy.
• Quality Assurance approval of Change controls in Quality Management System for documents, materials and equipment/process changes.
• Regularly reviewing change control activities to identify areas for improvement and ensure compliance with regulations.
• Investigate and resolve issues that arise during the approval of changes, working with relevant stakeholders to find solutions. 
• Monitor the effectiveness of change control processes and identify areas for improvement. 
• Maintain Quality Assurance documents such as training records, approved change control proposals, etc.
• Provide guidance and expertise on change control and document review practices to team members.
• Participate monitoring and communicating metrics to impacted stakeholders. 
• Communicates Quality-related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Quality Management or Designee.
• Participate in continuous improvement initiatives to enhance the effectiveness of the change control process. 
• Performs other duties as assigned or apparent.

Supplemental Functions: 

• Act as QA liaison and SME advisor on change control best practices, collaborating with Engineering, Facilities, IT, Manufacturing, and Validation teams. Educate functional owners on QA expectations, documentation completeness, and risk evaluation. 
• Act as QA approver for e-QMS, LIMS, ELN, CMMS, and any computerized systems governed by Part 11.
• Review and approve validation documentation—URS, IQ/OQ/PQ, test reports, risk assessments—ensuring proper implementation of Part 11 controls
• Approve system configurations, SOPs, user access controls, and vendor-supplied documentation to ensure compliance with 21 CFR Part 11, EU Annex 11, and data integrity principles.

Job Specifications and Qualifications 

Knowledge & Skills: 

• Technical background with strong understanding of quality assurance principles, cGMP and FDA regulations. 
• Written and Oral communications skills.
• Strong critical thinking, analytical, problem-solving, and interpersonal skills
• Strong attention to details and documentation.
• Strong organizational skills with the ability to manage multiple projects or assignments simultaneously.

· Ability to supervise, train, motivate and discipline employees.

• Team player, must be able to interact within the company with all departments.
• Work independently and dependable.
• Technical writing skills required with competency in Microsoft Word and Excel.
• Knowledgeable in Adobe Acrobat (PDF) advanced features and workflows
• Effective communication and interpersonal abilities to work with cross-functional, fast-paced teams.
• Ability to prioritize tasks, manage time efficiently, and meet deadlines.
• Effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• Discretion in handling sensitive and confidential information.

Education/Experience: 

• Minimum of 10 years of pharmaceutical experience in Quality Assurance preferably in reviewing and approving documents and change controls.
• Bachelors of Business Administration, Science, Information Management, or a related field is preferred.
• Previous experience with Quality Management Software is preferred (Trackwise, Trackwise Digital or Dot Compliance).
• 5-7 years of project management and leadership experience.  

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.
• Willingness to change direction and focus to meet shifting organizational and business demands.
• Individual may require to wear specified protective equipment if necessary
• Hours of work: Monday thru Friday on 8 hours shift, or as needed based on company demand.

The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. 

Nephron Pharmaceuticals 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.