American Regent, Inc. · 5 days ago
QA Compliance Program Supervisor
New Albany, OH
Full-time
Onsite
Mid, Senior Level
5+ years expAmerican Regent, Inc. is focused on compliance activities related to sterile injectables, and they are seeking a QA Compliance Program Supervisor. This role involves supervising compliance activities, managing quality programs, and ensuring procedural compliance across various functions.
Health CareMedical
Responsibilities
Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines
Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area
Responsible for management and continual improvement of the Annual Product Review (APR) Program
Responsible to oversee and improve the Gap Assessment Program, ensuring procedural compliance and alignment with regulatory compendia and corporate requirements
Oversees the Compliance Corrective and Preventive Action (CAPA) System. Work with owners and cross functional teams to ensure appropriate Corrective Action plans are assigned, implemented, closed in a timely manner, and verified for effectiveness in accordance with company SOPs, and policies
Provide day to day supervision and oversight of Quality Complaints
Responsible for overseeing the Field Alert Program in Ohio
Ensures procedural compliance and alignment with regulatory, compendium, and corporate requirements
Oversees the internal audit and Inspection Readiness Programs
Supports inspection/audit activities including ‘tactical room’ for all regulatory and customer audits
Provide technical expertise and mentorship regarding the internal audit program
Facilitate identification and resolution of objectionable cGMP issues which may impact quality and report to senior management
Identify quality process improvements to increase efficiencies and performance of systems, operations, and personnel
Evaluates, tracks and reports on all follow-up actions related to regulatory, corporate, or customer audits
Continually evaluate, generate, and present Quality metrics to Senior and Executive Management
Responsible for facilitating and supporting the Risk Management program
Perform any other tasks/duties as assigned by management
Qualification
Required
Bachelor's degree in Life Science, Quality Management, or related field or equivalent experience is required
Minimum 1 years' experience in a supervisory role required and/or has demonstrated the ability to lead, coach or mentor a team or group
Minimum 5 years' experience in QA, Regulatory Compliance or Pharmaceutical Operations in a cGMP manufacturing environment or similar FDA regulated environment is required
Understanding and experience in Risk Management tools and processes is required
Proficient in the use of electronic systems (e.g. - Microsoft Office, TrackWise, Veeva EDMS) and with willingness and ability to learn new systems
Excellent organizational, interpersonal and communication skills (oral and written)
Ability to work cross functionally and collaboratively with all departments at American Regent
Preferred
Working knowledge of application of statistical methodologies - experience with Six Sigma programs is a plus
Company
American Regent, Inc.
American Regent, Inc, a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics and hospitals across the United States and Canada.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Paul Diolosa
President & CEO
Joseph Boyle
VP Finance / CFO
Recent News
GlobeNewswire
2026-01-09
thefly.com
2025-08-28
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