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Director of Quality

Company: Homodeus
Location: Hartford
Posted on: September 17, 2020

Job Description:

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 you love.

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 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.

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 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 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 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 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, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.

Do you have experience in biotech and/or medical diagnostics?  *

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This role can be remote - are you willing to travel?  *

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Will you require work sponsorship now or in the future?  *

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U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Homodeus are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary . Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Gender Please select Are you Hispanic/Latino? Please select Please identify your race Please select Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran Status Please select Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability Why are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

Autism

Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS

Blind or low vision

Cancer

Cardiovascular or heart disease

Celiac disease

Cerebral palsy

Deaf or hard of hearing

Depression or anxiety

Diabetes

Epilepsy

Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome

Intellectual disability

Missing limbs or partially missing limbs

Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)

Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

Disability Status Please select 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: Homodeus, Hartford , Director of Quality, Other , Hartford, Connecticut

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