Director, Quality Assurance (QA)

About the Company:Our client is a leading venture backed pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Theirproducts are designed to deliver a drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner. This is a great opportunity to get introduced to a growing Bay Area Pharma company and learn new processes.Job DescriptionTitle:Director, Quality Assurance (QA)Location:Mountain View, CA 94043Salary:$185,000+ Dependent on ExperienceDirect HireJob Responsibilities:Lead all Quality Assurance functions for both commercial and clinical products manufacturing and developmentLead the development, implementation and maintenance of quality systems and related activities to ensure compliance to applicable regulatory requirements (e.g., deviations/CAPA process, Change Control and documents management, Quality procedures, validation program, product complaints program, and selection, evaluation and oversight of suppliers and service providersLead effort to develop phase-appropriate Quality SystemsLead CCB and MRB meetingsSchedule and participate in external and internal auditsResponsible for materials and product lot releaseServe as primary interface with Regulatory Agency inspectors during GMP inspectionsServe as primary interface on Quality Assurance matters with corporate partners and Ferrer Quality unitResponsible for Quality Management ReviewsResponsible for Product Quality Review reportResponsible for development and management of departmental budgetProvides mentorship to staffQualifications and Experience:BS in Life Sciences, Chemistry or related science disciplines10+ years Quality Assurance experience in pharmaceutical and/or medical device industryExperience in drug/device combination products is a plus, and experience in inhalation products is highly desirableComprehensive knowledge of cGMP regulations (US and EU), Quality Systems, ISO, and SOPs applicable to pharmaceutical and/or medical device organizationsExcellent verbal and written communication skillsStrong leadership ability, both within department and in cross-functional team settingsAbility to execute as well as leadAbility to exercise judgment within broadly defined practices and policies to evaluate and solve problemsSolid understanding of pharmaceutical and medical device developmentPlease submit an updated version of your resume for immediate and confidential consideration. Thank you!QualificationsQualifications and Experience:BS in Life Sciences, Chemistry or related science disciplines10+ years Quality Assurance experience in pharmaceutical and/or medical device industryExperience in drug/device combination products is a plus, and experience in inhalation products is highly desirableComprehensive knowledge of cGMP regulations (US and EU), Quality Systems, ISO, and SOPs applicable to pharmaceutical and/or medical device organizationsExcellent verbal and written communication skillsStrong leadership ability, both within department and in cross-functional team settingsAbility to execute as well as leadAbility to exercise judgment within broadly defined practices and policies to evaluate and solve problemsSolid understanding of pharmaceutical and medical device developmentPlease submit an updated version of your resume for immediate and confidential consideration. Thank you!Additional InformationPlease submit an updated version of your resume for immediate and confidential consideration. Thank you! #J-18808-Ljbffr