Head of Quality
Company: Patelco Credit Union
Posted on: February 23, 2021
- 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
- Directand oversee the quality planning and execution
- 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
- 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
Keywords: Patelco Credit Union, Bloomington , Head of Quality, Other , Columbus, Indiana
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