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Head of Quality

Company: Patelco Credit Union
Location: Columbus
Posted on: February 23, 2021

Job Description:

  • Category: Quality Assurance/Quality Control
  • Type: Full-time
  • Min. Experience: Director TheChief Quality Officer (CQO) is the lead position of the Quality Organizationand a member of the leadership team. TheCQO will provide strategic and operational leadership to establish, improve,and maintain the quality systems, policies, standards, and procedures. TheCQO is to ensure compliance with current US FDA, EMA and relevant ICH guidancedocuments. Ensure the Quality Organization is appropriatelyresourced and effectively executing a required state of quality and CGMPcompliance. The role includes themanagement of all quality oversight activities related to internal and externalmanufacturing, contract release and stability testing, and raw material suppliers. The CQO is responsible for assuring the QualityOrganization is adequately staffed in Quality Assurance (QA) and QualityControl (QC) by attracting and hiring experienced professionals, developing thetalent, and empowering the team. The CQOwill be a recognized across different functions as a partner and will continueto build a quality culture within the organization. CQO is the recognized role model by providingguidance and coaching to all levels within the Quality Organization and theleadership of the company. What Will You Be Doing?
    • Establishquality strategies to ensure CGMP compliance with US FDA, EMA and other internationalregulatory agencies regulations and expectations.
    • Directand oversee the quality planning and execution processes.
    • Developshort and long-term plans to achieve both quality and business objectives forthe organization.
    • Developthe quality policies strategy consistent with current regulatory expectationsfor rare diseases, and ensure that the quality policies and objectives are clearlycommunicated, implemented, and maintained within the organization.
    • --Ensure quality systems and processes areappropriate for the development stage of the product and the clinicalapplication.
    • Ensuremanufacturing, testing and release, and distribution of gene therapy products areconsistent and meet all relevant regulatory requirements including federal,state, and international regulations, applicable standards and regulatory guidance.
    • Developquality metrics and indicators to proactively identify and address qualitysystems or product-related issues.
    • Establishand lead a Quality Management Review (QMR) process to ensure continuedcompliance with CGMP standards.
    • Interfacedirectly with the FDA, EMA, other regulatory authorities and customer clientsto ensure the company is appropriately represented in all matters related tocompliance and quality.
    • Directcommunications with the regulatory authorities as appropriate. What Are We Looking For?
      • Musthave a Bachelor's degree in Microbiology, Chemistry, Biochemistry or relatedscience with > 15 years of work experience the biotechnology /biopharmaceutical industry and 10+ years of experience in a Quality role.
      • Over5 years Quality management experience.
      • Experiencewith leading a Quality Organization including QC and QA is highly desirable.
      • Musthave a comprehensive knowledge of US FDA, EMA, and ICH GxP regulations relatedto biopharmaceutical and gene therapy regulations and guidelines.
      • Musthave demonstrated experience with regulatory guidelines related to use of viralvector in human clinical applications including gene therapies and rare diseaseindications.
      • Experiencewith hosting and leading client, QP, and regulatory authority audits andinspections.
      • Develop,implement, and maintain procedures for GMP audit of suppliers/vendors. What is the highest level of education you've obtained? What is the highest level of education you've obtained? We invite you to complete the optional self-identification questions below used for compliance with government regulations and record-keeping guidelines. Any self-identification information provided will not be considered in the selection process. GENDER Male Female Nonbinary I do not wish to self-identify my gender ETHNICITY Hispanic/Latino White (Not Hispanic or Latino) Black/African American (Not Hispanic or Latino) Native Hawaiian/Other Pac Island (Not Hispanic or Latino) Asian (Not Hispanic or Latino) American Indian/Alaska Native (Not Hispanic or Latino) Two or More Races (Not Hispanic or Latino) Decline to Specify If you believe you belong to any of the categories of protected veterans listed below, please indicate by selecting the appropriate category(ies). The hiring employer is a Government contractor subject to the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended by the Jobs for Veterans Act of 2002, 38 U.S.C. 4212 (VEVRAA) and requests this information in order to measure the effectiveness of the outreach and positive recruitment efforts it undertakes pursuant to VEVRAA. Disabled Veteran Armed Forces Service Medal Veteran Veteran who served on active duty during a war or in a campaign or expedition for which a campaign badge has been authorized Recently Separated Veteran Veteran, but not one of the four protected classes above I decline to state my veteran status Not a Veteran Because the hiring employer does business with the government, it must reach out to, hire, and provide equal opportunity to qualified people with disabilities. Answering this question is voluntary, but we hope that you will choose to complete it. 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. Yes, I have a disability (or previously had a disability) No, I don't have a disability I do not wish to answer this question

Keywords: Patelco Credit Union, Bloomington , Head of Quality, Other , Columbus, Indiana

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