Posted on Alex Kramer / in US Jobs

Director of Quality Assurance

Who we are

binx is improving sexual health and wellness through new delivery methods that prioritize clinical integrity and consumer privacy and convenience. We provide a first of its kind, comprehensive digital program that includes evidence-based sexually transmitted infection (STI) testing, counseling, treatment, and follow up in order to increase screening and reduce infections.

Our proprietary desktop, PCR-based, 30-minute, point of care testing platform and consumer mobile offerings break down screening barriers through discreet patient-tailored and individualized digital approaches that complement traditional brick-and-mortar care.

Director of Quality Assurance

This role will report directly to the Chief Operating Officer and will have responsibility for leading all aspects of quality strategy development and ensuring all related activities are performed in accordance with FDA, EU and other applicable regulatory standards and guidelines.  This position will play a critical role in determining, implementing and maintaining an internal infrastructure that is compliant with the QSR, 21 CFR Part 820.

This position has quality enforcement responsibilities and as such requires the highest level of professionalism best manifested in leading by example and supporting a culture of inclusion and transparency.  The individual must be an excellent teacher so as to instruct team members at all levels of the company on compliance with international regulations.

Responsibilities:
  • Key leader in the development and simplification of binx’ quality management system.  Leads the investigation, selection and implementation of an eQMS.
  • Understands the concepts of least burdensome compliance with regulations as balanced with the need for design, manufacturing, distribution and commercial controls.
  • Acts as the Management Representative in compliance with ISO 13485 5.5.2 and 21 CFR Part 820.20
  • Understands the application of risk based decision making and operates comfortably formulating and presenting risk based strategy and tactical plans.
  • Leads a value-added auditing program designed to audit regulatory compliance within a framework of relative importance and risk.
  • Ensures that all the manufacturing and quality programs relevant to the manufacturing of the Company products, such as process and manufacturing development, validation plans, production, release, and labeling, are appropriately structured to meet US, European, and other regulatory requirements.
  • Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through sharing of knowledge, expertise, and relevant information.
  • Interprets and communicates regulatory expectations to internal and external stakeholders (including partners, supply chain, service providers, CROs, consultants, and contractors) in order to execute program objectives in compliance with applicable regulations.
  • Promote the development of a company-wide understanding of the key elements related to quality and regulatory compliance requirements.
  • Support the regulatory team in the preparation and submission of marketing approval applications (510(k)s, CE Marking, Design Dossiers, International Licenses, etc.).
  • Develop and execute quality design and quality assurance strategy for new product development and sustaining business activities.
  • Leads and builds a world-class Quality Assurance team to help enable Company growth.
Experience that matters to us
  • 7-10 years+ of experience building and implementing effective quality management systems for clinical in-vitro diagnostics companies. Experience with molecular diagnostics a plus.
  • Proven record of leadership and managing quality organizations with global responsibility and establishing long term strategic growth initiatives.
  • Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization.
  • Experienced in assisting regulatory teams with filings for US (510(k), IDE and PMA) and other key countries/regions.
  • Demonstrated success in the development and implementation of quality management systems and assuring compliance to all applicable regulations.
  • ‘Creative thinker’ with the ability to develop novel solutions to challenging problems.
  • High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
  • Excellent interpersonal and strong leadership skills; self-motivated and flexible to changing schedules.
  • Willingness to regularly travel to our UK offices
Individual Traits
  • Thinks and humbly challenges
  • Open to and encourages inquiry and debate; intellectually curious
  • Gritty; resilient and determined
  • Willing and able to get in the details to design and maintain a best in class QMS
  • Focuses on execution and outcomes, not on effort
The good stuff
  • Competitive salary, commensurate with experience
  • Benefits: Medical, Dental, Life and Disability insurance, 401(k) plan with matching, paid vacation and holidays, stock options

For interested applicants, please submit resumes to: careers@mybinxhealth.com