Licensing Specialist

Our External Licensing Specialist plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include managing and overseeing the license vetting process, ensuring compliance with legal requirements, obtaining necessary licenses and permits from customers and vendors as applicable, and maintaining accurate records. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.What The External Licensing Specialist Does Each DayReviews licensing requirements and develops strategies to meet regulatory obligationsVerifies all licenses match the required criteria while onboarding new customersVerifies data and profile set up in INFOR comply with federal and state requirements for 503B industryEnsures all onboarding license documentation is accurate, complete, and submitted within specified timelinesTracks expiration dates and initiates renewal process in a timely manner to prevent any disruption in shippingMaintains and updates customer licenses via customer portal submission for all existing customersCollaborates with internal stakeholders to gather necessary information and documentation to resolve any licensing discrepanciesConducts regular internal reviews to ensure ongoing compliance with licensing requirements for all existing customersIdentifies and addresses any potential compliance gaps or issues proactivelyPrepares reports and documentation as required by regulatory agencies or internal stakeholders during an auditEffectively communicates with a diverse group of people, in varying settings to facilitate the licensing process and ensure Quva Pharma operates within regulatory guidelinesStays updated on relevant laws, regulations, and industry standards to ensure compliance with 503B, DEA, BOP, DHHS, FDA guidelinesProvides accurate and timely updates on licensing status, changes, and compliance matters to relevant partiesContinuously assesses, enhances efficiency, improves licensing processes, and ensures adherence to best practicesIdentifies areas for automation or technology solutions to optimize the licensing processPerforms the investigation and research that fall within Pharmacy Services for licensing related issuesWrites and reviews standard operating procedures related to Pharmacy ServicesEstablishes & maintains cooperative cross-functional relationships w/peers across all sites in Customer Service & Commercial Operations to meet corporate objectivesUnderstands SOPs, cGMP & regulations to accomplish daily tasksParticipates in team projects and meetingsOur Most Successful External Licensing SpecialistHas a sense of urgency, accountability and resourcefulnessIs a self-starter, independent learnerPromotes active listening with team members; Contributes appropriately to conversations; Strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organizationUnderstands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transformMinimum Requirements For This RoleBachelor’s degree in a relevant field, such as business administration, legal studies, or regulatory affairsMinimum 2 years’ prior experience in cGMP / FDA regulated industry or PharmacyExcellent technical writing and verbal/written communication skillsStrong knowledge of licensing regulations, laws, and compliance requirements in the applicable industryWell versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP’s and have demonstrated strength in problem solving and resolution Able to successfully complete a drug and background checkMust be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visasAny Of The Following Will Give You An EdgeTexas Pharmacy Technician RegistrationBenefits Of Working At QuvaComprehensive health and wellness benefits including medical, dental and vision401k retirement program with company matchA minimum of 17 paid days off plus 8 paid holidays per yearNational, industry-leading high growth company with future career advancement opportunitiesAbout QuvaQuva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva’s overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is “at will.”California Consumer Privacy Act (CCPA) Notice for Applicants and Employees