At GenapSys we are working to power the world of healthcare and diagnostics with advanced DNA sequencing technology. Our sequencing instrument platform leverages a proprietary electrical microfluidic sequencing chip with a scalable number of detectors, enabling a wide range of applications including targeted sequencing in oncology, pharmacogenomics and genome-wide sequencing in microbiology and others. We believe in a world where every researcher has a compact, scalable, and affordable sequencer in their own lab, empowering the democratization of genetic sequencing. Our novel sequencing method is revolutionizing genomics discovery, biomedical research, healthcare, diagnostics, agriculture, and a variety of other fields.
Our team brings together an incredibly diverse and multidisciplinary set of backgrounds and skills – from electrical and mechanical engineers, physicists, chemists, microfluidic engineers, molecular biologists, bioinformaticians, mathematicians and more. It is a super exciting time to join GenapSys as we recently launched our first product which is generating a tremendous amount of interest.
About the Role:
We are looking for a Head of Quality and Regulatory Affairs. You will have overall responsibility for leading the development and management of the quality management system including the setting of quality goals, managing and improving all aspects of the quality system with an emphasis on regulatory compliance, customer experience, design controls and code and solution quality, production controls and process performance, risk management and quality management governance to ensure compliance and drive measurable improvement in product and service quality. Provide thought leadership for the development and implementation of regulatory strategies and work with the marketing, product, operations and legal teams to shape and evolve value propositions
- Lead the corporate culture transformation efforts with respect to quality. Develop the Company’s Quality Control Management System and quality and regulatory improvement program
- Partner with the Leadership Team to create a culture of quality and compliance in all we do.
- Successfully develop, build and deliver Regulatory and Quality Assurance training
- Work with marketing, the Customer Success leader and the operations team, HR and others to ensure that customer measures and Voice of Customer input is appropriately reflected into all internal policies, practices and processes to include all development, operations and customer facing roles.
- Responsible for the Company’s Quality Control Management System to ensure compliance with federal and state regulatory requirements and software development best practices.
- Development and execution of Quality Assurance processes which enable rapid product development and product commercialization
- Stay abreast of the changing regulatory landscape and serve as the subject matter expert for the Leadership team on all regulatory matters. and product offerings related to healthcare reform and value based care
- Oversee efforts to ensure compliance with applicable security, privacy and federal health care regulations and program requirements
- Provides counsel, training, and interpretation of regulatory authorities’ feedback, policies, and guidelines in coordination with the Legal Department.
- Collect data from internal/external audits and reports metrics and trends in order to implement process improvements
- M.B.A. or other relevant advanced degree in life sciences, engineering or business
- 10+ years in regulated industry, healthcare preferred, in quality, regulatory and clinical experience in a HCIT, pharmaceutical, life sciences technology or medical device driven company
- Experience in strategic planning and collaboration with executive and key operational groups
- Progressive & proven record of leadership and managing quality/regulatory/clinical organizations and developing and managing a company’s QMS in a regulated environment
- Experience with all phases product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization
- Display highly effective coaching abilities as well as a successful track record of developing staff and internal employee base as we establish a deepened quality culture and adherence to a Quality Management System.
- High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction
- Excellent communications and presentation skills. Ability to lead, influence, create and work within cross-functional team environments
- Assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude and a sense of urgency to get things done
- Well organized, creative, strategic thinker equally capable of tactical execution and driving results, as well as articulating unique ideas and perspectives
- Can develop plans and processes that emphasize acceleration of development cycles & optimization of product development, as well as the leadership skills to effectively implement
- Ability to work in a results-oriented, project -–driven, team environment
- Ability to prioritize projects and deliver quality results within tight time constraints
What we offer (US based-employees)*:
- Competitive compensation and generous stock options.
- Comprehensive, industry-leading medical, dental and vision benefits for employees and dependents.
- Pre-tax savings plans for health care, child care, elder care, public transportation and parking expenses.
- 401(k) retirement plan with matching employer contribution.
- Free daily catered gourmet lunches and snacks.
- For those emergency moments - long and short term disability, life insurance (2x salary) and an employee assistance program.
- Work with driven and enthusiastic colleagues in a fast-paced and entrepreneurial environment, the opportunity to work on problems that matter in a highly collaborative environment.
*Eligible international employees’ benefits are specific to their location and dependent on their employer of record
GenapSys does not accept unsolicited agency resumes. Please do not forward unsolicited agency resumes to our website or to any GenapSys employee. GenapSys will not pay fees to any third party agency or firm and will not be responsible for any agency fees absent a formal agreement.
A diverse and inclusive workplace where we learn from each other is an integral part of GenapSys' culture. We actively welcome people of different backgrounds, experiences, abilities and perspectives. We are an equal opportunity employer and a great place to work. Join us and help us achieve our mission!