Senior Quality Management Systems Specialist

Job Description Senior Quality Management Systems Specialist provides coordination and reporting that includes data collection, generation, analysis, and interpretation. In addition, prepares summary findings to support change controls, planned deviations, new product launch compliance, and quality assurance trends related to various quality management processes. Essential Functions Reviews and approves data for change, implementation, analysis, and reporting. Collects and generates data for analysis and reporting, supports preliminary investigations, prepares summaries for NOIs, CAPAs, complaints, and other quality‑related activities, and audits completed tasks for reporting purposes, identifying outstanding actions for both sterile and non‑sterile quality operations. Reviews all change controls and planned deviations, issues tasks, monitors due dates, and follows up until tasks are completed and events are closed. Coordinates preparation, review, and approval of new product launches within required time frames and tracks all commitments to the agency for both sterile and non‑sterile quality operations. Prepares, reviews, and presents/ submits quality data with a statistical approach; serves as a subject‑matter expert for electronic QMS. Provides senior quality management leadership with timely data analysis and insights to support compliance, proposes corrective actions and improvements. Notifies QM management of activities or decisions that may impact compliance or lead to regulatory action. Prepares or ensures extension documentation is in place for activities that cannot meet scheduled due dates. Collaborates with personnel from other functional areas to collect information, coordinate discussions, and facilitate resolution of quality issues and concerns, distributing documentation as applicable. Acts as a point of contact for assigned responsibilities toward external audits, maintaining required documentation supporting regulatory audits. Regularly audits investigations and CAPA schedules for reporting purposes, identifying possible outstanding actions. Additional Responsibilities Assists with internal and regulatory audits as requested; analyzes, displays, and customizes data reports in formats such as scorecards and presentations on a bi‑weekly, monthly, and quarterly basis. Qualifications Education: Bachelor’s Degree (BA/BS) in Pharmacy, Chemistry, Biotechnology, or a related field – required. Experience: 4 years or more in related QA field experience. Specialized Knowledge: Organized, creative, and able to communicate thoughts and ideas clearly; able to present data and trends in an easily understood and relatable manner. Additional Requirement: This position requires successful completion of an OSHA‑compliant respirator fit test. Compensation & Benefits Base salary: $105,000 to $115,000 per year. Benefits include a comprehensive, flexible, and competitive health and insurance package, a significant 401(k) matching contribution, and programs supporting employee well‑being. Equal Opportunity Employer Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any portion of the hiring process, please contact us at View email address on click.appcast.io. Requests will be handled confidentially and in accordance with applicable laws. #J-18808-Ljbffr Amneal Pharmaceuticals