Global Vice President, Regulatory Quality Affairs
Biofourmis, United States
Job Description
Biofourmis is a rapidly growing, global digital health company filled with committed, passionate professionals who care about augmenting personalized care and empowering people with complex chronic conditions to live better and healthier lives. We are pioneering an entirely new category of medicine by developing clinically validated, software-based therapeutics to provide improved outcomes for patients, smarter engagement amp; tracking tools for clinicians, and cost-effective solutions for payers. We are collectively devoted to a single-minded idea: powering personally predictive care.
Our dynamic growth has been marked by quadrupled headcount in the last 12 months via both expansion amp; acquisition, yielding a global footprint with offices in Boston, Singapore, Bangalore, and Zurich. We are backed by prominent international venture capital investment amp; have cultivated relationships with worldwide healthcare stakeholders over the last 5 years. Our talented team features numerous PhD’s in Data Science and Biostatistics, over 80 patents, prolific scientific publications, world-class systems, developers amp; engineers, and leaders in the clinical operations space.
Global Vice President, Regulatory amp; Quality Affairs
To realize our robust pipeline, we are seeking a talented and highly motivated executive to join our organization as Global Vice President, Regulatory amp; Quality Affairs. The successful candidate will be responsible for strategic and functional leadership of Regulatory and Quality initiatives supporting our core platform amp; broad integrated solution portfolio. This seasoned professional will play a critical role as a core member of our Executive Management Team building the quality and regulatory foundation for our strategic pursuit of growth opportunities in the field of digital therapeutics.
Key Responsibilities:
- Direct all activities relating to U.S. FDA and analogous international regulatory compliance, such as clinical research and pre-clearance testing, post-beta commercialization, required clearances and approvals, compliance with quality systems regulations, and other analogous requirements.
- Lead Quality throughout the entire global organization by elevating to a performance standard expected from a leading multinational digital health companyincluding training, strategic amp; tactical guidance, systems building amp; management, amp; regular communication with each vertical.
- Manage a team of high performing Regulatory and Quality professionals to drive excellence within the organization.
- Develop and implement effective strategies for obtaining necessary regulatory approvals to bring products to market with optimum cost effectiveness and compliance.
- Ensure timely preparation and filing of organized and scientifically valid submissions.
- Design record retention practices and oversees audit preparations.
- Provide expertise in translating regulatory requirements into practical, workable plans.
- Represent the Company in interactions with relevant regulatory agencies.
- Already possess or have the ability to build strong relationships with relevant global regulatory bodies to effectuate timely submission clearances.
- Develop effective systems and ensures compliance with the Company’s global quality assurance programs, including design, manufacturing and test, product assurance, reliability, training, and documentation.
- Support new product development efforts, including assigning Quality representatives to Product Development Core teams. Provide critical inputs to and/or approvals of all design control elements including test development, protocols, reports, inspection instructions, Design Reviews, Design History Files, etc.
- Support certification and ongoing compliance processes to all relevant ISO, FDA and international standards (ex. ISO 13845, QSR etc.) by facilitating the development, implementation, monitoring, and improvement of Biofourmis quality management systems and practices
- Manage and strengthen the infrastructure required to perform the core activities of the Quality Management System, including Deviations, Out of Specification (OOS), Corrective amp; Preventative Actions (CAPAs), investigations, change control, validations, material disposition, complaints, internal and external audit/inspections, and customer inquiries/questionnaires
- Collaborate with other functions to assure compliance in support of biopharma services, clinical validation studies, regulatory interactions, and medical device commercialization.
- Build functional excellence within the Regulatory and Quality organization through excellence in hiring, ongoing professional development amp; performance management, and organizational design.
- Maintain an up-to-date knowledge of regulatory procedures to provide analysis an