Quality Manager

pstrongPhibro Animal Health Corporation /strong is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals. /ppPhibro is a diversified company in manufacturing and marketing products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets. In addition to, Phibro’s revenues are in excess of $1 billion and are supported by over 2,300 employees worldwide. /ppAt Phibro, people are our greatest asset. We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful that they can be. /ppIf you are interested in working for Phibro and feel that you do not meet all qualifications, we encourage you to apply as you might be the right candidate for this role or other positions. /ppThe Quality Manager is an integral part of our Quality team based out of our Medolla, Italy site. /pulliSite Quality responsibility to provide technical expertise leadership for Quality compliance topics/issues. /liliProvide strategic guidance with management related to QA operations, approaches to deviation investigations improvements to ensure robust performance. /liliEnsure schedules for review approval of GMP documents are developed maintained to meet the commercial supply timelines. /liliProvide sound support to operations, engineering, supply chain material movement for commercial products. /liliEnsure relevant QA documents procedures are approved to schedule to support technology transfers NPIs. /liliProvide strategic leadership for deviation investigations, including root cause analysis corrective preventive action proposals initiatives. /liliLead QA review approval of SOPs, batch process records, policies, validation protocols reports. /liliDevelop objectives for the QA department direct reports, monitor performance progress against departmental objectives prepare performance reviews development plans for direct reports. /liliProvide support expertise for the preparation of regulatory submissions, inspection readiness activities during health authority inspections including leading audits with inspectors, responses to inspection observations monitoring progress of follow up actions. /liliSupport audits of GMP material suppliers Providers executed according to PAHC Supplier Management/audit program. Provide support for improvement follow up CAPAs. /liliConduct work activities in compliance with Safety, Health and Welfare at Work legislation Company policies. /liliOther duties as assigned. /li /ulpstrongCOMPETENCIES /strong /pulliHave achieved a satisfactory level of technical professional skill/knowledge in position related areas, keep up with current developments trends. /liliStrong technical knowledge as it applies to QMS, QA related regulatory requirements. /liliAn understanding of EU GMP, ICH, HACCP (Feed Safety Risk Assessment/Management) and compendia regulations guidance for Veterinary Medicinal Products Feed Additives. /liliProven ability to manage complex quality issues, direct cost, effective quality programs deliver against Quality metrics. /liliIdentify understand issues, problems opportunities compare data to draw conclusions develop solutions consistent with the facts. /liliAbility to form strong relationships cross functionally. /liliAlways be aware of conditions that affect employees product safety. /liliSet high standards of performance; assume responsibility accountability for successfully completing assignments/tasks. /li /ulpstrongEducation/Experience /strong /pulliAdvance degree (Masters, PhD) in a technical discipline (e.g. biochemistry, chemistry, pharmacy) minimum of 7 years’ experience in a GMP Quality environment with a minimum of 3 years in a managerial role: or equivalent combination of education experience is required. /liliQP Eligibility Experience Of Releasing Batches Is Required. /liliMinimum of 7 years’ relevant experience within a pharmaceutical (preferably Veterinary) industry/related field is desirable. /liliMinimum of 3 years’ experience as a named QP for manufacture of commercial medicines is desirable. /liliDemonstrated success records in leading regulatory audits is desirable. /liliIn depth knowledge of current regulatory requirements for manufacturing technology in support of GMP operations supporting commercial manufacturing is desired. /liliDirect experience of GMP management within a pharma/biopharma company is essential will include exposure to Health Authority inspections/audits certifying 3rd party organizations desirable. /liliDemonstrated success in quality management the resolution significant quality/technical challenges desirable. /li /ulpstrongPhibro is an Equal Opportunity Employer /strong /ppAll qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law. /ppstrongBusiness Unit: Animal Health Mineral Nutrition /strong /ppstrongDepartment: Quality /strong /ppstrongWork Schedule: Monday - Friday (40 Hours) /strong /p #J-18808-Ljbffr