Detect’s mission is to empower individuals to have greater ownership of their health with rapid, low-cost home and point-of-care diagnostics. We build breakthrough technology at the intersection of software, hardware, chemistry, and biology. We use this technology to champion a new era of personalized healthcare and help end the COVID-19 pandemic.
Detect is a well-funded, rapidly growing health-tech company founded by award-winning scientist and highly successful serial entrepreneur, Dr. Jonathan Rothberg. Detect benefits from being a 4Catalyzer company, an incubator of biotech and med device companies (most notably Butterfly Network) who have collectively raised over $700 million in funding.
Joining Detect is the opportunity to redesign the future of healthcare through the power of technology. Embark on a journey with us to maximize global impact, motivated by the idea that our products will change the lives of millions along with the people you love.
The Head of Quality will drive and implement Quality Management Systems in line with the company’s global Quality objectives, ensuring that businesses processes across business units, global function and metrics are aligned to create highest product quality and competitive advantage.
As part of our team, your core responsibilities will be:
- Responsible for substantially strengthening Quality systems, driving Quality into our designs and determining, standardizing the appropriate functional system infrastructure and tools (problem solving and risk management) required to reach the quality level.
- Promote quality throughout the company and execute Quality roadmap established with executive team.
- Plan, implement and advance the quality systems at all levels of the organization.
- Oversees and conducts analysis to assure effectiveness into our final product meeting customer requirements and internal quality standards.
- The position will provide leadership for Quality activities to drive product development programs and ensure the Company’s ongoing compliance with regulatory mandates.
- The position may also be extended to include oversight for the company’s broader regulatory activities and initiatives
- Must be a dynamic leader with outstanding communication, strategic and collaboration skills, and will provide adept supportive leadership.
- Works with Product Development and Contract Manufacturing teams during technology transfer of new product start-ups, establishing key checkpoints for new products and processes, and managing change implementation.
- Directs compliance audits as required.
- Reviews and approves regulatory submissions.
- Interfaces with regulatory agencies as required representing the company to authorities and regulatory inspectorates.
- Reviews, approves, and directs implementation of changes to controlled documents and processes (e.g., SOPs, Specifications, Methods, etc.) as needed.
- Directs a wide variety of activities to ensure compliance with quality systems, quality procedures, quality policies and applicable regulatory requirements to facilitate compliance with regulatory agencies and business requirements.
- Responsibilities include the final release of commercial products for national and global markets.
- Directs and mentors’ staff in complex technical complaints, investigations, regulatory agency correspondence and recall management.
- Assures all relevant complaints are escalated to Risk Analysis and/or Situational Analysis
- Represents company as host of regulatory GMP inspections at applicable contract sites and supports inspections at CMO facilities.
- Occasional travel as needed.
- Other duties as assigned.
- Bachelor’s degree Life/Health Sciences; Master’s degree and/or Ph.D. a plus
- Minimum 15 years of leadership experience within a Quality and Product Development Organization.
- 5+ years of Quality leadership/management experience in an associated director or higher-level position.
- 5+ years of experience in a significant operational excellence, business transformation or continuous business process improvement environment
- Experience implementing quality and business process improvement initiatives in a global, discrete manufacturing environment.
- Strong analytical and problem-solving skills possessing proven record on quality tools.
- Demonstrated leader, change agent, influencer, coach and team builder.
- Prefer hands-on experience implementing Quality initiatives in manufacturing, field service, and transactional areas.
- Experience in all phases of regulatory submissions and interactions, including post-approval experience; international experience desired.
- Experience with database management abilities.
- Experience with documentation systems and with document review and auditing.
- Excellent communication skills, team members that can work collaboratively with colleagues across all functions.
- Excellent analytical, presentation, writing, and computer skills are required.
- Comprehensive knowledge of current US and ex-US regulatory guidelines, desired.
- Demonstrate excellent leadership and communication skills.
- Demonstrate strong organizational skills, including the ability to prioritize personal workload.
- Extensive supervisory experience and ability to guide, train, supervise and prioritize workload of direct reports.
- Senior managerial experience in a fast paced company environment is desirable.
- Ability to work well in a deadline-driven environment.
- Capable of supporting multiple projects simultaneously.
You Deeply Identify with Core Detect Values:
- Efficient & Speedy - you get work done in a fraction of the time as industry peers
- Intellectually Curious - you are thoughtful & inquisitive; people enjoy working with you because they learn from you
- Mission-Driven & Committed - you are passionate about the company's purpose and are immensely productive
- Team Oriented - you celebrate and take joy in the success of others on the team
We offer great perks:
- Fully covered medical insurance plan, and dental & vision coverage - as a health-tech company, we place great worth on our teams’ well-being
- Competitive salaried compensation - we value our employees and show it
- Equity - we want every employee to be a stakeholder
- Pre-tax commuter benefits - we make your commute more reasonable
- Free onsite meals + kitchen stocked with snacks.
- 401k plan - we facilitate your retirement goals
- The opportunity to build a revolutionary healthcare product and save millions of lives!
Detect does not accept agency resumes.
Detect is an E-Verify and an equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.