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PharmaForce, Inc. QA Compliance Program Manager in New Albany, Ohio

Nature and ScopeReporting to the QA Compliance and Systems Sr. Manager, the QA Compliance Program Manager focuses on the team Management 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 ResponsibilitiesNothing 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 to a team including: individual goal setting/performance reviews/development plans, managing the development of employees including their skills and competencies, 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 Annual Product Review (APR) ProgramManage 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, policies.Provide day to day management and oversight of Quality Complaints.Manage personnel and program for ensuring procedural compliance and alignment with Regulatory, compendium, and corporate requirementsManages the Internal Audit and inspection readiness programsEvaluates, tracks and reports on all follow-up actions related to Regulatory, corporate, or customer auditsContinually Manage, evaluate, generate, and present Quality System metrics to Senior and Executive ManagementManagement of Risk management program.Perform any other tasks/duties as assigned by management.Education Requirements and QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.Bachelors in Life Science, Quality Management, Business or related field preferredMinimum 8 years' experience in Quality Systems Compliance or Pharmaceutical Operations in a cGMP manufacturing environment or similar FDA regulated environment is required.Minimum 5 years' experience in Management of a team 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 systemsWorking knowledge of application of statistical methodologies - experience with Six Sigma programs is a plus.Excellent organizational, interpersonal and communication skills (oral and written).Ability to work cross functionally and collaboratively with all departments at American Regent.Optional StatementsAbility to work overtime as needed.American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. American Regent Inc. endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact Roz Russo, Talent Acquisition Senior Manager at 631-205-2068 or email at We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic pr

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