Full Description

Nature and Scope 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. Education Requirements and Qualifications To 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. 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. Working 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. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make https://careers.americanregent.com/ 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 email hrtalentacquisition@americanregent.com. Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide.