Top 988 Audit supervisor Jobs in Remote

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- Bachelor's degree
- US work authorization
- Health insurance
- Dental insurance
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Manager, Government Audit
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University of Colorado Medicine —Remote
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Devoted Health —Remote
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LBMC, PC —Remote
- Full-time
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GCP Quality Assurance Manager

TotalMed Medfi -
Alameda, CA

Quick Apply

Job Details

Contract
$75 - $93 an hour
13 days ago

Benefits

Health insurance
Dental insurance
401(k)
Vision insurance

Qualifications

Quality control corrective actions
Regulatory inspections
Clinical research audit management
Audit engagement planning
Drug regulation
Corrective and preventive actions (CAPA)
Vendor compliance audits
Supplier audits
Clinical audit and monitoring
ICH guidelines
Bachelor's degree
Pharmaceutical company experience
Quality improvement
Clinical quality assurance standards
FDA regulations

Full Job Description

The Manager GCP Quality Assurance applies established knowledge and experience with Good Clinical Practice GCP regulations guidelines and local legislation to lead and execute GCP QA activities in support of global clinical trials by providing guidance and support on the interpretation and application of Good Clinical Practice GCP regulations and guidelines to Clinical teams. This role will contribute to ensuring the conduct of clinical trials documents investigator sites systems and vendors is compliant with the requirements of GCP through the conduct of audits of clinical studies investigator sites internal processes vendors e.g. CROs and documents e.g. CSRs. The Manager should have a solid knowledge of ICH GCP E6 R3 and applicable 21 CFR regulations and be able to apply that knowledge to support clinical trial activities. The Manager will also partner with study teams to create a quality culture to provide compliance guidance and contribute to reaching a sustained state of inspection readiness.

RESPONSIBILITIES:

Partner cross-functionally to support the successful and compliance execution of clinical trials
Contribute to the development of the GCP audit plan
Conduct and/or oversee the conduct of audits of clinical investigator sites internal GCP systems and processes external vendors and clinical trial documents
Identify and report systemic issues and improvement opportunities with the assistance of management/senior auditor as necessary
Independently perform audits including preparation conduct presentation and reporting
Assist in assessing proposed CAPA plans
Support GCP Regulatory Authority inspections
Contribute to the continued development of a quality culture.

Requirements:

Required minimum of 5 years of related experience in biotech pharmaceutical or related industry
Working knowledge of FDA EMA ICH GCP guidelines and GCP regulations e.g. ICH E6 R3
Experience working with CROs and vendors
Experience planning conducting and reporting all types of GCP audits e.g. investigator sties processes vendorsKnowledge Skills and Abilities:

#INDZH

Pay: $75.00 - $93.00 per hour

Benefits:

401(k)
Dental insurance
Health insurance
Vision insurance

Education:

Bachelor's (Required)

Experience:

GCP Quality Assurance Management: 4 years (Required)

Work Location: Remote

Quick Apply

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audit supervisor jobs in remote

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