Principal/ Senior Auditor, Quality Assurance

CTI Clinical Trial and Consulting Services; Região Geográfica Intermediária de São Paulo; Presencial; BRL 120.000 - 160.000; Tempo integral

Resumo da oferta

A leading clinical trial and consulting services company is seeking a Principal/ Senior Auditor in Quality Assurance. This role involves maintaining regulatory knowledge, providing compliance guidance, and leading quality assurance training initiatives. Ideal candidates will have 8-10 years of relevant experience, strong communication skills, and a comprehensive understanding of GCP/ICH guidelines.

Serviços

Career progression support

Tuition reimbursement

Structured mentoring program

Work-life balance support

Global philanthropic program

Qualificações

• 8 – 10 years experience in clinical (GCP) quality assurance or relevant experience.
• Bachelor’s Degree or equivalent combination of education and experience.

Responsabilidades

• Evaluate CTI processes for continual process improvement.
• Prepare audit plans for audits and projects as needed.
• Conduct Vendor Audits and clearly communicate audit outcomes.

Conhecimentos

Excellent verbal and written communication skills

Comprehensive understanding of GCP/ICH Guidelines

Excellent analytical skills

Ability to work effectively in a team environment

Risk identification and mitigation

Formação académica

Bachelor’s Degree or equivalent

Ferramentas

MS Word

Excel

PowerPoint

Descrição da oferta de emprego

Principal/ Senior Auditor, Quality Assurance

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Principal/ Senior Auditor, Quality Assurance

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About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit

www.ctifacts.com

• Maintain significant knowledge in regulatory requirements and ICH GCP principles
• Provide regulatory compliance guidance and quality improvement consult to internal and external customers
• Evaluate CTI processes for continual process improvement and provide leadership for implementation
• Employ risk identification and mitigation strategies related to identified and potential compliance issues
• Prepare training materials and conducting training related to relevant QA topics
• Report, manage and follow deviations, complaints, issues, non-conformances and their related CAPAs
• Prepare audit plans for audits and projects and programs, as needed
• Assist the organization in preparation for, coordination, hosting, conduct, documentation and follow-up of regulatory inspections
• Host Sponsor audits at CTI and Assure that issues from Sponsor audits are promptly communicated to the appropriate team members, assist with the development of a corrective action plan and facilitate resolution of all audit findings
• Assist with quality assurance training for junior CTI quality assurance staff
• Conduct Vendor Audits, Internal System Audits, Site Audits and Computerized Systems and Database Validation Audits
• Clearly communicate and report (verbally and in writing) audit outcomes and escalate significant compliance concerns to project teams, QA and CTI management and sponsor contacts appropriately
• Conduct Sponsor-contracted audits, such as: Clinical Study Report Audits, Clinical Protocol Audits, Clinical Database Audits, Investigator Site Audits, etc on an ad hoc or scheduled basis as determined by the Sponsor and CTI management
• Assist with creation, review, revision and management of SOPs
• Assist with completion of RFIs related to Quality Management Systems
  
  
• Excellent verbal and written communication skills
• Comprehensive understanding of GCP/ICH Guidelines and relevant regulations
• Computer literacy in MS Word, Excel and PowerPoint
• Excellent prioritization and organizational skills
• Excellent analytical skills
• Ability to work effectively and successfully in a team environment
• Ability to think critically and creatively
• Ability to work independently, ensuring quality and consistency in deliveries
  
  

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

What You´ll Do:

• Maintain significant knowledge in regulatory requirements and ICH GCP principles
• Provide regulatory compliance guidance and quality improvement consult to internal and external customers
• Evaluate CTI processes for continual process improvement and provide leadership for implementation
• Employ risk identification and mitigation strategies related to identified and potential compliance issues
• Prepare training materials and conducting training related to relevant QA topics
• Report, manage and follow deviations, complaints, issues, non-conformances and their related CAPAs
• Prepare audit plans for audits and projects and programs, as needed
• Assist the organization in preparation for, coordination, hosting, conduct, documentation and follow-up of regulatory inspections
• Host Sponsor audits at CTI and Assure that issues from Sponsor audits are promptly communicated to the appropriate team members, assist with the development of a corrective action plan and facilitate resolution of all audit findings
• Assist with quality assurance training for junior CTI quality assurance staff
• Conduct Vendor Audits, Internal System Audits, Site Audits and Computerized Systems and Database Validation Audits
• Clearly communicate and report (verbally and in writing) audit outcomes and escalate significant compliance concerns to project teams, QA and CTI management and sponsor contacts appropriately
• Conduct Sponsor-contracted audits, such as: Clinical Study Report Audits, Clinical Protocol Audits, Clinical Database Audits, Investigator Site Audits, etc on an ad hoc or scheduled basis as determined by the Sponsor and CTI management
• Assist with creation, review, revision and management of SOPs
• Assist with completion of RFIs related to Quality Management Systems
  
  

Competencies:

• Excellent verbal and written communication skills
• Comprehensive understanding of GCP/ICH Guidelines and relevant regulations
• Computer literacy in MS Word, Excel and PowerPoint
• Excellent prioritization and organizational skills
• Excellent analytical skills
• Ability to work effectively and successfully in a team environment
• Ability to think critically and creatively
• Ability to work independently, ensuring quality and consistency in deliveries
  
  

What you´ll Bring:

• 8 – 10 years of progressive experience in clinical (GCP) quality assurance or relevant pharmaceutical and/or CRO experience in Quality Assurance
• Bachelor’s Degree or equivalent combination of education and experience
  
  

Why CTI?

• We support career progression – We have a structured mentoring program to provide the support you need to move forward
• We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
• We value our people - We have never had a layoff in our 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade
• Our culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
• We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (click here to learn more about our “CTI Cares” program)
• We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate (a recent report found that the average turnover for CROs in the US was 30%)
• Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
  
  

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Research Services

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