US Affiliate Quality Manager
 Ceva Animal Health, LLC | |
 United States, New Jersey, Bridgewater | |
 Jan 11, 2025 | |
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US Affiliate Quality Manager The success of a company depends on the passionate people we partner with. Together, let's share our talents. Your U.S Affiliate Quality Manager Location: Remote, US Working with the Director of US Commercial Compliance, ensure that a quality system is implemented and maintained, following all the specific responsibilities of this position. Responsibilities and Key Duties: 1) Ensuring that a quality system is implemented, maintained and aligned with the corporate guidelines. 2) Focusing on the management of authorized activities and the accuracy and quality of records. 3) Ensuring that initial and continuous training programs are implemented and maintained. 4) Ensuring that all products are subjected to a proper arrival inspection process. 5) Approving product to be distributed to the market (commercial release) by collaborating with inspection staff at Ceva's warehouses. 6) Coordinating and promptly performing any recall operations for products on the market following the related escalation and market event management processes. 7) Primary/preferred reference contact with the authority regarding quality and market events and certification audits for quality endorsements like NASC. 8) Ensuring that relevant customer complaints are dealt with effectively. 9) Ensuring that suppliers and customers are approved. 10) Negotiating with commercial distributors to develop contracts that detail a Quality system between the entities to allow reporting of product quality defects and adverse drug experience reports generated from the field to meet the needs of Ceva and our distributor partners. 11) Approving any subcontracted activities which may impact good distribution practice (qualification through audit and QA agreement). 12) Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and ensuring that the necessary CAPA are put in place. 13) Keeping appropriate records of any delegated tasks. 14) Deciding on the final disposition of returned, rejected, recalled or falsified veterinary medicinal products. 15) Approving any returns to saleable stock. 16) Ensuring that any additional requirements imposed on certain veterinary medicinal products by national or state laws are adhered to. 17) Documenting deviations and deciding on CAPA to correct deviations and avoid their reoccurrence and monitoring of the effectiveness of those CAPA. 18) Ensuring that post-approval marketing studies are duly approved by the relevant instances prior to being conducted. 19) Assure labels meet Ceva's quality standards. Core Competencies: * Shape solutions out of complexity * Client focus * Collaborate with empathy * Engage and develop * Drive ambition and accountability * Influence others Technical / Functional Competencies: * Ability to lead an audit with relevant time management, investigation posture, adaptability approach, and interpersonal relationship skills. * Knowledge of pharmaceutical development, regulatory, and manufacturing sciences with global overview. * Bring a comprehensive risk approach to the quality management system. Proficiency in continuous improvement tools to solve complex issues. * Expert knowledge of the regulations governing the pharmaceutical industry in the US. Capability to challenge counterparts and adapt solutions. * Advanced level in use and mastery of office software. * Knowledge of quality systems tools and how to apply them to comply with local regulations. Qualifications: Education - BA/BS required (Scientific discipline preferred). Work Experience - Minimum of 5 years industry experience with quality systems. Other - Expert knowledge of regulations governing the manufacturing, warehousing, and distributing pharmaceutical and animal health products in the US. Demonstrated ability to learn and understand regulations and navigate through bureaucratic processes. Impeccable attention to documentation and detail. Physical Requirements: Ability to read, speak and understand English. Must be able to read, speak, hear, and see. Working Conditions: Ability to work remotely. Must provide reliable high-speed internet access. Travel Required: Travel required up to 20% of the time. Mostly domestic but may require a few international trips. This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties, and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business. *VEVRAA Federal Contractor **Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply. 685C Your Qualifications: Education - BA/BS required (Scientific discipline preferred). Work Experience - Minimum of 5 years industry experience with quality systems. Other - Expert knowledge of regulations governing the manufacturing, warehousing, and distributing pharmaceutical and animal health products in the US. Demonstrated ability to learn and understand regulations and navigate through bureaucratic processes. Impeccable attention to documentation and detail. | |