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MMS
Atlanta, GA, United States
Job Description Job Description MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make
Job Source: MMSConfidential
Atlanta, GA, United States
Senior Director, Quality Compliance & Systems About the Company Popular provider of infant nutrition products Industry Health, Wellness and Fitness Type Privately Held, VC-backed Founded 2016 Employees 201-500 Funding $101-$200 million Categories Health Care Nutrition Wellness Health & Wellness Health and Wellness Consumer Goods Food Production He
Job Source: ConfidentialCardinal Health
Atlanta
**_What Quality Compliance contributes to Cardinal Health_** Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Compliance is responsible for the development and deployment of policies, procedures and programs designed to minimize r
Job Source: Cardinal HealthCardinal Health
Atlanta
**_What Quality Compliance contributes to Cardinal Health_** Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Compliance is responsible for the development and deployment of policies, procedures and programs designed to minimize r
Job Source: Cardinal HealthSuperior Essex
Atlanta, GA, United States
Job Description About Superior Essex: Superior Essex stands at the forefront of innovation, leading the global charge in designing, manufacturing, and supplying advanced communication cables. As a global leader in shaping the future of connectivity, our commitment to innovation, quality, and sustainability underscores everything we do. We believe
Job Source: Superior EssexIntercontinental Exchange Holdings, Inc.
Atlanta, GA, United States
Overview: Job Purpose This position will be responsible for developing, leading, and performing information technology (IT) audits and perform Sarbanes-Oxley IT controls testing. This position must be able to manage and conduct audits of general business and information technology functions in supporting the execution of the annual audit plan. Res
Job Source: Intercontinental Exchange Holdings, Inc.Intercontinental Exchange
Atlanta, GA, United States
Overview Job Purpose This position will be responsible for developing, leading, and performing information technology (IT) audits and perform Sarbanes-Oxley IT controls testing. This position must be able to manage and conduct audits of general business and information technology functions in supporting the execution of the annual audit plan. Res
Job Source: Intercontinental ExchangeIntercontinental Exchange Holdings, Inc.
Atlanta, GA, United States
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Job Source: Intercontinental Exchange Holdings, Inc.Atlanta, GA, United States
MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO inGlobal Health & Pharma’sinternational awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn .
Job Specific Skills:
Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates.
Understanding of how to plan, prepare andconduct GCP auditsindependently.
Proficient in authoring and managing audit documents independently.
Experience in reviewing and editing QMS related documents, i.e., SOPs, Work Practices, Forms, Training Materials, etc. independently.
Develop CAPA plans and contribute to resolution of audit findings independently.
Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently.
Assists in other duties relating to overall compliance within Quality and Compliance department, as requested.
Must be willing to travel up to 75% of the time for audits within the US and potential travel to Canada.
Requirements: College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years’ experience in GCP regulated industry if not a college graduate
Minimum of 5 years’ experience inGCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.)
Expert knowledge of scientific principles and concepts.
Reputation as emerging leader in field with sustained performance and accomplishment.
Proficiency with MS Office applications.
Hands-on experience with clinical trial and pharmaceutical development preferred.
Good communication skills and willingness to work with others to clearly understand needs and solve problems.
Excellent problem-solving skills.
Good organizational and communication skills.
Proficient with 21 CFR Part 11, FDA, and GxP requirements.
Expertise within CROs and scientific and clinical data/ terminology, and the drug development process.
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Email Alert for Senior Quality and Compliance Specialist (GCP Auditor) jobs in Atlanta, GA, United States
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