Director, Quality Assurance

The Director, Quality Assurance position is responsible for managing all Quality Assurance and Quality Systems departments supporting all aspects of compounding sterile pharmaceuticals and regulatory compliance within the facility. This position operates within the legal and regulatory compliance, producing a quality product. This leader operates the area as the supervisor over the QA and QS staff, coordinating roles and responsibilities and projects. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement.This is an onsite role located in Bloomsbury, New Jersey. What the Director, Quality Assurance Does Each Day:Supervises QA & QS managers by providing learning and development where appropriateAbility to make Quality decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operationsManages the on-time release of batchesManages the on-time initiation and closure of Deviations / Investigations, CAPAs, Change Controls with thorough & standardized supporting documentationManages others to ensure appropriate SOPs and training documents are in place & effectiveManages others to ensure the design and maintenance of the environmental monitoring program including environmental and personnel monitoring are adequate and in placeManages others to ensure QuVa quality standards are met at the site so that processes are the same as other QuVa sitesMaintain compliance with FDA 503B and cGMP guidelines / state and federal lawsPrepares and submits weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunitiesManages others to maintain site documents supporting the commercial manufacturing & release of sterile injectable productsManages the design and implementation of site policies and proceduresEscalates to VP of Quality critical issues jeopardizing manufacturing & release of a safe & effective product that meets regulatory requirementsPromptly communicates with Operations regarding complaints, product issues/variancesEnforces applicable personnel policies and proceduresOur Most Successful Director, Quality Assurance has / is:Technical writing and communicationWell versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP’s and have demonstrated strength in problem solving and resolutionStrong interpersonal skillsStrong oral and written communication ability, including presentation skillsInterpersonal skills demonstrating the ability to interact with people holding positions in manufacturing, both operations and quality including compounders, pharmacist, supervisors, area management, quality specialist as well as functional areas such as Human Resources, IT, Customer Service, Finance and Pharmacy Services.Development of action plans to meet a specific objective including identification and methods of tasks, milestones, resources requirements and metrics.Successful Time management skills in order to coordinate successful accomplishment of an approved action plan with timelines and milestone tasks.Understanding of process flows, gap assessments and analysis of data to drive improvementProficiency with computerized tracking toolsComprehensive knowledge of adult learning techniquesMinimum Requirements for this Role:EducationExperience18+ years of ageAble 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 visasBachelor’s Degree in Life Science or other related fieldMinimum 10 years prior experience in Quality Assurance / cGMP / FDA regulated industryMinimum 5 years of supervisory or management experience Experience with aseptic techniques and appropriate gowning techniques supporting manufacturing of sterile injectable productsBenefits of Working at Quva:Comprehensive health and wellness benefits including medical, dental and vision401k retirement program with company match20 PTO + 5 PLP paid days off plus 8 paid holidays per yearNational, industry-leading high growth company with future career advancement opportunitiesThe base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditionsRange: $163,764 - $225,881 AnnuallyThis role is also eligible for an annual incentive bonus, subject to program terms and guidelinesAbout Quva:Quva 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 EmployeesJob SummaryRequisition Number: DIREC006148Job Category: 8000-QualitySchedule: Full-Time