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Director of Quality Systems

Company: Jobot
Location: Phoenix
Posted on: November 23, 2021

Job Description:

Want to join an Oncology Up and Comer?! We're looking for a Director of Quality Systems!!This Jobot Job is hosted by: Dorothy TownsendAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $120,000 - $160,000 per yearA bit about us:My client is a growing precision medicine lab company. We conduct in-house lab testing on tissue samples, primarily cancer biopsies, to provide Oncologists better intel on how to improve their patient's outcomes.Why join us?We are expanding our presence in the Southwest and looking to double in size in 2022. We offer a competitive salary and bonus structure in addition to the benefits below:

  • Medical, Dental Vision
  • 401(k) Match or Roth
  • PTO and Holidays
  • Short & Long term Disability
  • Employee Assistance Program
  • Basic Life/A&D and Optional Life/A&D
  • Flex Spending Accounts
  • Legal Plans
  • Pet Insurance
  • Tuition AssistanceJob DetailsPosition Summary:The Director of Quality Systems is primarily responsible for providing quality oversight, defining strategies for implementation and continual improvement of the Quality System and support at our company. The position will work in collaboration with the Laboratory Operations, Product Development and Regulatory teams to provide QA oversight throughout the product lifecycle.Job Responsibilities:Implement and provide oversight of development and commercial change controls, Risk Management, GMP investigations, associated CAPAs and Effectiveness Checks. Lead the investigation/CAPA triage meetings (as necessary) and collaborate with customer groups to ensure quality systems are monitored and established metrics are met.Establish and generate performance metrics, trends; including site metrics for investigation/CAPA, management review, etc.Lead compliance walkthroughs of the site and help drive the closure of observations.Participate in inspection readiness activities and provide support during regulatory site inspections.Regulatory Inspection preparation, support internal preparation in the overall regulatory inspection covering inspection preparations, execution of regulatory inspections, preparation of responses to health authorities and inspection follow-up.Support internal and external audit plans for company development programs.Perform data audits of documentation intended for submission to regulatory health authorities (e.g. FDA, EMA).Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication.Act as a trusted advisor to the leadership team by providing compliance guidance through collaborative review and working to gain a better understanding of their needs and facilitate resolution of quality issues in a timely manner.Required Qualifications:Master's degree with minimum 7 years of relevant work experience, or Bachelor's degree in a scientific or related field with minimum 10 years of relevant work experience, or relevant comparable background.Working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems.Demonstrated success independently working with cross-functional teams.Experience providing QA support and oversight of GMP manufacturing operation including batch release.Experience in hosting regulatory inspections.Experience with equipment, facilities and utility system qualifications activities in a GMP setting.Experience successfully leading event investigations, Risk Management (ISO 14971), Root Cause Analysis (RCA), and CAPA.Excellent technical report writing skills.Strong communication, interpersonal and problem-solving skills and detail oriented.Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening and reference verification. Also, individual must be fully vaccinated for COVID-19 by the date of hire to be considered for U.S.-based jobs.Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

Keywords: Jobot, Phoenix , Director of Quality Systems, Executive , Phoenix, Arizona

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