Senior Director Quality

Company: Anivive Lifesciences
Location: Long Beach
Posted on: March 25, 2020

Job Description:

Anivive Lifesciences Inc. is a Long Beach, CA biotech company utilizing proprietary technologies to change the way new animal drugs and vaccines are evaluated, selected, and developed.We are specifically focused on the unmet medical needs of pets, developing a diverse pipeline of innovative products, targeting various cancers, infectious diseases, and endocrine conditions.This role will provide management for the functional areas of the Quality organization.----The Quality Senior Director ensures that the quality systems are effectively established, maintained and that all personnel are in compliance.------The role will be the primary contact for inspections and audits of all Anivive entities and contract organizations.Job duties:Develop, implement and maintain quality programs/systems, processes, procedures and reporting systems that follow ICH guidance, FDA, EMA, CVM and global authority regulations and other relevant guidancesPromote GXPs (GMP/GCP/GLP, etc.) and assess quality of Anivive and its third partiesAuthor and maintain Anivive SOPs and ensure that personnel are in compliance with training systemLead audit and inspection preparation/readiness, coordinate resolution of findings and liaise with auditing groups and inspectors through all stages of the auditPlan, conduct/coordinate GXP audits and inspections for all CRO/CMOs.Prepare periodic Quality Management reports to Anivive managementAuthor internal quality system documents (e.g., Change Controls, Deviations, CAPAs) and provide to internal and external stakeholdersIdentity opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulationsComply with FDA, CVM, USDA and other international regulatory regulation requirements/standards, company policies, operating procedures and processesSupport the quality operations for R&D and commercial operationsHandle clinical and marketed product complaints and recallsProvide oversight of vendor/supplier management programAbility to travel up to 25%Qualifications:Bachelor's degree or higher in Biology, Chemistry, Engineering, or Pharmacy with a minimum of fifteen years of progressively increasing responsibility and work experience in Quality, Engineering and/or R&D in the pharmaceutical industryTen or more years of service with increasing responsibility within a management role in a Quality function.Experience in the Animal Health industry is desirable.Knowledge of the pharmaceutical R&D process and ability to apply GMPs in conformance to US, EU and international standardsExperience in performing GMP and internal audits with direct US and international health authority inspections and interactionsDemonstrated strong root cause analysis skillsBroad cross-disciplinary knowledge and experience with industry-accepted QA design methodologies and project managementDemonstrated ability to work collaboratively within a geographically diverse business environment and personnelProven leadership skills in a Quality roleStrong verbal and written communication skills with an ability to effectively communicate at multiple hierarchal levelsAdvanced credential(s) in relevant Quality disciplinesFor additional information please contact:Brian CarilloDirector of Pharamceutical SciencesAnivive Lifesciences3250 Airflite Way, Suite 400Long Beach, CA 90807bcarrillo@anivive.com(201) 320-0187

Keywords: Anivive Lifesciences, Long Beach , Senior Director Quality, Executive , Long Beach, California