QA Compliance Program Supervisor

American Regent•New Albany, OH

11d

About The Position

Reporting to the QA Compliance & Change Control Sr. Manager, the QA Compliance Program Supervisor focuses on the supervision of compliance activities at American Regent. This is a multi-disciplinary management role that will interact with all phases of the product lifecycle regarding sterile injectables at all Ohio locations. Essential Duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. 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.

Requirements

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.

Nice To Haves

Working knowledge of application of statistical methodologies - experience with Six Sigma programs is a plus.

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.