Head of Quality Management Systems
Posted on 3/29/2023

1,001-5,000 employees

Genetic testing medical care company
Company Overview
Invitae believes that good health is possible—and that genetic information has the ability to transform the way medicine is practiced, making what once seemed impossible possible, as they empower people to make decisions about their health through the power of genetics.
Remote • United States
Experience Level
  • Bachelor of Science degree or equivalent
  • 15+ years of experience in the biologics industry, preferably in a laboratory setting, with a minimum of 10 years of leadership experience
  • Experience working in a regulated facility; CLIA/CAP, ISO 15189, ISO 13485, ISO 9001, GCLP, FDA
  • Auditor (or related) certification i.e., ASQ, CAP, ISO 15189, BSI, Oriel STAT A Matrix, FDA, etc
  • Experience hosting inspections from regulatory agencies
  • Experience conducting audits: internal and/or external 3rd party
  • Significant experience leading teams and managing quality systems staff
  • Strong communication skills and ability to effectively communicate with people at all levels of an organization
  • Ability to interpret policies, procedures, and regulatory requirements
  • Ability to make decisions impacting product and sample safety based on independent judgment and discretion
  • Demonstrated ability to analyze already existing operations for quality assurance deficits and proactively design interventions and monitoring procedures to correct deficits
  • Completes all required EHS training. Wears appropriate PPE as required. Complies with applicable federal, state, and local regulations, Invitae EHS policies and procedures and the
  • Requirements of accrediting organizations and works in a safe and responsible manner
  • This salary range is an estimate, and the actual salary may vary based on a wide range of factors, including your skills, qualifications, experience and location. This position is eligible for benefits including but not limited to medical, dental, vision, life insurance, disability coverage, flexible paid time off, Spring Health, Carrot Fertility, participation in a 401k with company match, ESPP, and many other additional voluntary benefits. Invitae also offers generous paid leave programs so you can spend time with your new child, recover from your own illness or care for a sick family member
  • USA National Pay Range
  • $224,600-$291,900 USD
  • Please apply even if you don't meet all of the “What you bring” requirements noted. It's rare that someone checks every single item, it's ok, we encourage you to apply anyways
  • Join us!
  • At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance. We truly believe a diverse workplace is crucial to our company's success and to better serve our diverse patients. Your input is especially valuable. We'd greatly appreciate it if you can take a quick moment to make your selection(s) below. Submissions will be anonymous
  • You can find a detailed explanation of our privacy practices here
  • Design quality improvement initiatives and other quality systems activities, including procedures for monitoring implementation success
  • Responsible for oversight of Enterprise QA “systems” including audits, non-conformity management, change control, shipping kit management and clinical trials
  • Manage QA systems staff performance and employee development
  • Update and revise procedures as applicable
  • Performs and/or delegates appropriately, the duties of the Audit Program Manager (APM)
  • Coordinate Site Internal Audit program to ensure compliance with the Invitae Quality System
  • Conduct internal audits of clinical laboratory testing facilities in compliance with internal audit management system procedure
  • Coordinate and manage internal audit schedule
  • Partner with laboratory leaders to ensure Internal Audit program supports the preparation for external audits and opportunities for improvement
  • Participate in monthly expanded RA/QA management team meetings
  • Support the tracking, monitoring, and presentation of quality systems metrics for QA meetings
  • Support the implementation of corrective actions arising from audit observations and investigations as necessary
  • Support the supplier qualification program and perform audits as needed