Homodeus’ 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.
Homodeus is a well-funded, rapidly growing health-tech company
founded by award-winning scientist and highly successful serial
entrepreneur, Dr. Jonathan Rothberg. Homodeus 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 Homodeus 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
Job Description 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
Promote quality throughout the company and execute Quality
roadmap established with executive team.
Plan, implement and advance the quality systems at all levels of
Oversees and conducts analysis to assure effectiveness into our
final product meeting customer requirements and internal quality
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
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
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
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
Occasional travel as needed.
Other duties as assigned.
Qualifications 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
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
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 with database management abilities.
Experience with documentation systems and with document review
Excellent communication skills, team members that can work
collaboratively with colleagues across all functions.
Excellent analytical, presentation, writing, and computer skills
Comprehensive knowledge of current US and ex-US regulatory
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
Ability to work well in a deadline-driven environment.
Capable of supporting multiple projects simultaneously.
You Deeply Identify with Core Homodeus 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 suc cess of
others on the team
Additional Information We offer great perks:
Fully covered medical insurance plan, and dental & vision
coverage - as a health-tech company, we place great worth on our
Competitive salaried compensation - we value our employees and
Equity - we want every employee to be a stakeholder
Pre-tax commuter benefits - we make your commute more
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 liv es!
Homodeus does not accept agency resumes.
Homodeus is an E-Verify and an equal opportunity employer
regardless of race, color, ancestry, religion, gender, national
origin, sexual orientation, age, citizenship, marital status,
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Do you have experience in biotech and/or medical diagnostics?
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