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
Notice to recruiting agencies: Theranos, Inc. ('Theranos') does not accept unsolicited resumes from recruitment agencies, search firms, headhunters, or staffing agencies. Please do not forward resumes to our careers alias or to any employee, contractor or consultant of Theranos. Any unsolicited resume submitted will be considered property of Theranos, and we will not be obligated to pay any fee associated with such resume.
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