Theranos is actively building a world-class team. Most likely candidates are currently employed or have been employed in similar types of positions but want to be part of a paradigm-shifting company doing innovative work and gain tremendous personal and career growth. Candidates must be hard working with unfaltering determination to excel in an intense start-up environment.
Major duties will include developing, implementing and overseeing the company’s QA/QC systems and controls in accordance with GMP and other key regulatory standards. The successful candidate will direct the staff responsible for the testing of regulated products to assure ongoing quality and compliance of all company products.
Role & Responsibilities:
Establish and maintain systems, policies and procedures to ensure product quality and compliance
Work with R&D and manufacturing to ensure internal groups and outside suppliers meet applicable quality standards
Ensure that SOPs, MOPs, validations, CAPA’s and internal audits are reviewed, approved, implemented and completed in a timely manner
Ensure compliance of the document control program
Develop and oversee training program to ensure GMP compliance and internal training requirements
Develop and oversee validation activities for products, processes, facilities and computer systems including 21 CFR part 11
Development and oversight of QA/QC budget
Development of quantitative testing for products from design through commercialization
Develop stability protocols and studies
Review analysis of internal and external quality data to detect trends and monitor product quality
Provide QA oversight of manufacturing, quality and clinical documents that are submitted to regulatory agencies
The successful candidate will be a highly qualified and experienced executive who has an excellent record of building and managing successful QA/QC teams at companies which have been successful at developing and commercializing technology in the healthcare space. Our finalist will thrive in an environment of above and beyond standards.
10+ years of QA management experience in the healthcare industry
BA/BS or equivalent (advanced degree a plus)
Strong knowledge of CMS and FDA regulations and guidance; knowledge of HIPAA preferred
Experience hiring and training technical personnel
Strong communication, leadership, interpersonal and team building skills
Strong knowledge of Microsoft Office
State or Province