Quality Assurance Associate Director, Pharmacovigilance - civica rx : Job Details

Remote About Civica: Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports. Shortages put patients at risk and waste hospital resources. Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states. Civica's mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers. Civica's new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status. The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica's work to manufacture and distribute affordable medications. The Foundation's first commitment is to support Civica's efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients. Join us. Learn more at www.civicarx.org Job Description: The Quality Assurance (QA) Associate Director, Pharmacovigilance, will lead Civica, Inc. ( Civica ) pharmacovigilance and product quality complaint oversight functions in developing and supplying essential generic quality and biosimilar medicines and combination products by bringing their knowledge and experience to serve patients and pursue excellence in quality and compliance. The QA Associate Director, Pharmacovigilance is responsible for leading the quality oversight within the Quality System to ensure compliance with cGMP and GCP requirements, SOPs and regulatory standards for Civica's product portfolio across generics and biosimilars, including combination products. The QA Associate Director, Pharmacovigilance will have a minimum seven (10) years related experience in managing quality assurance processes for pharmacovigilance, and product quality complaints. As a leader, the QA Associate Director possesses competencies including, but not limited to, continuous process improvement, analyzing information, strategic planning, written and verbal communication, instilling excellence, attention to detail, problem solving and addressing complex situations. The position is a remote role. Essential Duties and Responsibilities: Lead Civica pharmacovigilance and product quality complaint functions including but not limited to ensuring:Quality and operations systems comply with FDA and other applicable regulations and requirements by providing support and guidance on the interpretation of regulations and industry best practicesCivica's third party provider for pharmacovigilance and product quality complaint reporting meets Civica and FDA requirements and regulationsProduct quality complaints, adverse drug events, and medical device reports are reported and investigated with follow-up as necessaryQA support in inspection preparation and hosting pharmacovigilance related regulatory inspections, including pre-inspection and follow-up activitiesSupport of vendor qualification and re-qualification audits of pharmacovigilance and safety related vendors as needed to support business needs and ensure complianceManagement of Safety Data Exchange Agreements with Private Label Manufacturers and Market Authorization Holders.Trending and analyzing complaint dataCommunicate compliance requirements at all levelsCoordinate product quality complaint investigations with internal manufacturing siteEnsure visibility to and manage awareness of any noted deviations, issues or deficiencies by escalating to managementEstablish procedures for combination product complaintsReview of Civica Regulatory filings, Information requests and related reports and technical documentation for compliance with regulations, guidance, and industry standardsReview and assess changes to regulatory requirements and industry best practices and facilitate implementation through new or revised processesEstablish, monitor and track processes and metrics which measure the level of risk of studies, programs and sitesPerform other related duties as required Basic Qualifications and Capabilities: Minimum Bachelor of Science (B.S.), Nursing, or PharmD degreeOver ten (10) years of experience in the pharmaceutical industry, preferably in Pharmacovigilance / Safety roles3-5 years leadership experience managing pharmacovigilance quality management systems, including combination productsDemonstrated understanding of GXP requirements for compliance with domestic and international regulations including those of the US FDA and other applicable agencies in biologics, oral solid dosage product and/or combination productsStrong interpersonal, verbal and written communication skills including technical writing skillsMust understand a variety of quality systems that support the product development lifecycle and post marketing arenaSolid problem solving and critical thinking skillsPrevious experience in preparing for and hosting/responding to regulatory health authority inspectionsAbility to lead projects with minimal supervision required; to work independently and in a team-based environmentAbility to effectively plan, organize, monitor, execute, and measure success of a projectAbility to anticipate and adjust to rapidly changing priorities and anticipate the impact of the change on overall programDemonstrated ability to develop and implement business processes and process improvements Physical Demands and Work Environment: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate. The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable. PandoLogic. Category: Quality Control, Keywords: Quality Control / Quality Assurance Analyst