Job Summary:

The Senior Software Quality Manager manages the Software Quality group at the Boston-area Facility to develop and implement strategies and policies consistent with Company Goals in an ever-changing regulatory climate. The Senior Software Quality Manager ensures that Corporate Software initiatives are delivered in a compliant and timely manner and that strategies, SOP’s and development processes are understood and executed. This position ensures compliance in a fast evolving developmental, medical device, clinical laboratory and commercial environment. The Senior Software Quality Manager will prepare, evaluate and oversee software testing strategies.

Reporting to the Director of Software Quality and Data Privacy, this role will manage internal Software quality professional staff and/or consultants and direct and implement advancement of the Software Quality functions of PatientsLikeMe and HealthTell as members of the iCarbonX Digital Life Alliance.

Major Duties and Responsibilities:

  • Develop quality strategies and act as the software quality liaison for development projectsSupport and monitor software quality control activities with adherence to the internal quality management system and pertinent Global QSR requirements for complex products and digital platforms
  • Develop, maintain and continuously improve software quality standard operating procedures
  • Work with supplier quality to approve software vendors and contractors.
  • Support software change control activities, CAPA investigations, reviews, approvals, and/or CAPA plan implementations as needed.
  • Train staff in quality policies or procedures.
  • Travel up to 25%.
  • Other duties as assigned

Qualifications: 

  • BS/BA degree in computer science, engineering or related discipline.
  • Minimum of 8 years of industrial experience in Software Quality or related discipline.
  • Working knowledge of FDA Quality System Regulations (21 CFR Part 820 and Part 11) ISO 13485 (Quality Management for Medical Devices, Clinical Laboratory Improvement Amendments (CLIA) of 1988 and IEC62304. 

Special Skills, Abilities, and Requirements

  • Exceptional written, oral, and interpersonal communication skills.
  • Working knowledge of different software development life cycles (waterfall, iterative) and contemporary software quality assurance processes and automated tools.
  • Experience in research and consumer products which are then further developed into diagnostic and medical devices preferred.
  • Strong management and cross-group skills, including the ability to get what you need from others while working around their own legitimate priorities.
  • Statistical knowledge a plus
  • Ability to work in a complex, rapidly changing environment
  • Excellent project management skills
  • Strong leadership and mentoring skills
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive
  • Demonstrated strong problem solving and risk management skills.
  • Quality engineering certification (ASQ CQE or CQA) desired

About iCarbonX Digital Life Alliance

PatientsLikeMe and HealthTell are now a central part of iCarbonX’s Digital Life Alliance; this represents an unprecedented ecosystem of leading bio, health networking, sequencing and artificial intelligence technology companies. The alliance is working to combine biological and patient generated data with artificial intelligence technology to more rapidly detect meaningful signals about health, disease and aging, deliver a personalized guide for living a healthy life, and help industry learn even more about how to improve outcomes, and lives.

About PatientsLikeMe

PatientsLikeMe, the world’s largest personalized health network, helps people find new options for treatments, connect with others, and take action to improve their outcomes. The company has worked with every major pharmaceutical company and a range of government organizations to bring the patient voice to research, development and public policy. With 600,000 members, PatientsLikeMe is a trusted source for real-world disease information and a clinically robust resource that has published more than 100 research studies.

About HealthTell

HealthTell is a well-funded Life Sciences company that is commercializing the ImmunoSignature™ technology for accurate and timely detection, and monitoring progression of chronic diseases. Based on a robust, scalable, proprietary technology, the company will provide the first and only diagnostic platform capable of detecting the presence of disease, stratifying patients, and monitoring disease progression. The ImmunoSignature™ technology is unlike any other, measuring the immune system instead of relying on inaccurate biomarkers or radiographic images.  The ImmunoSignature™ Test will enable physicians to detect disease at an early stage, resulting in improved outcomes and reduced healthcare expenditures. 

 HealthTell is an equal opportunity employer.

 

Apply for this Job
* Required
(Optional)
Almost there! Review your information then click 'Submit Application' to apply.

File   X
File   X


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at PatientsLikeMe 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.

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.


Form CC-305

OMB Control Number 1250-0005

Expires 1/31/2020

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

Because we do business with the government, we must reach out to, hire, and provide equal opportunity to qualified people with disabilities1. To help us measure how well we are doing, we are asking you to tell us if you have a disability or if you ever had a disability. Completing this form is voluntary, but we hope that you will choose to fill it out. If you are applying for a job, any answer you give will be kept private and will not be used against you in any way.

If you already work for us, your answer will not be used against you in any way. Because a person may become disabled at any time, we are required to ask all of our employees to update their information every five years. You may voluntarily self-identify as having a disability on this form without fear of any punishment because you did not identify as having a disability earlier.

How do I know if I 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:

  • Blindness
  • Deafness
  • Cancer
  • Diabetes
  • Epilepsy
  • Autism
  • Cerebral palsy
  • HIV/AIDS
  • Schizophrenia
  • Muscular dystrophy
  • Bipolar disorder
  • Major depression
  • Multiple sclerosis (MS)
  • Missing limbs or partially missing limbs
  • Post-traumatic stress disorder (PTSD)
  • Obsessive compulsive disorder
  • Impairments requiring the use of a wheelchair
  • Intellectual disability (previously called mental retardation)
Reasonable Accommodation Notice

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

1Section 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.