Senior GCP QA Auditor (Clinical Research)

Contenido de trabajo

Remote Opportunity

Summary:

The Work we do at IQVIA impacts lives all over the world. At IQVIA, the Largest Human Data Science Company in the world, we accelerate innovation for a healthier world. Come and join us to help our customers and partners do extraordinary things for healthcare!

The IQVIA Enterprise QA team is a dynamic, talented, and experienced global team that owns the global Quality Management System for the Largest Human Data Science Company in the world. The QA function is responsible for driving compliance in a highly regulated industry through audits, functional support, issue & CAPA management, regulatory consultancy, management of data analytics and customer relationship interactions. These services ensure our clinical research activities are of the highest quality. We proactively support our business partners and help to drive innovation. Continuous improvement is a core capability, and we value strategic thinking, creativity and operational excellence.

We seek highly motivated people who truly want to make a difference in the life sciences industry and are looking for opportunities to impact the business and be part of the solution. At IQVIA, we support our colleagues with a focus on succession planning, career progression and continuous learning.

The workplace is remote and located in Canada, USA, or LATAM. The travel requirement is about 50% in Americas.

Purpose:

A Sr QA Auditor is responsible for providing support to Management in the promotion and assessment of compliance with regulations, guidelines, operating procedure. Collaborates with internal project teams to proactively promote, support and facilitate proactive quality through the identification and management of risks and implementation of quality improvement activities. Provide consultation in interpretation of regulations, guidelines, policies, and procedures.

Summary of Responsibilities:

• Plan, schedule, conduct, report and close any type of GCP audits (e.g., investigator site, eTMF, database, vendor audits, process audits) conducted on-site or remotely.
• Conduct audits in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions.
• For each audit, deliver an audit report and review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans.
• Verify completion of the CAPAs as agreed in IQVIA electronic Quality Management System (eQMS).
• Conduct joint audit with junior auditors or experienced auditors for training, coaching, and/or more complex audits as needed.
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
• Provide consultation to project teams and auditees in interpretation of audit observations and formulation of corrective action plans
• Present educational programs and provide guidance to operational staff on compliance procedures
• Provide quality assurance consultancy activities and projects for clients within budget and established timelines
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
• May be asked to host/co-host audits/inspections as needed.
• Contribute to the development of innovative audit strategy and audit tools.
  

Required Education and Experience:

• Minimum 5 years of experience in a pharmaceutical, biotech, CRO, or other regulated area, of which 3 years are in Quality Assurance GCP auditing.
• Bachelor’s degree in a scientific or healthcare-related field
• Demonstrated experience leading and successfully delivering on GCP audits
  

Required Knowledge, Skills and Abilities:

• Experienced in the conduct and reporting of GCP audits for Phase I to Phase IV studies (e.g., investigator sites, eTMF, database, Clinical Study Report, process, third-party vendor)- on site, remote, primarily in Americas and globally (remote)
• Knowledge and experience working with ICH-GCP guidelines
• Knowledge of Word-processing, spreadsheet, and database applications.
• Extensive knowledge of pharmaceutical research and development processes and regulatory environment
• Knowledge of quality assurance processes and procedures
• Strong interpersonal skills
• Excellent problem solving, risk analysis and negotiation skills.
• Strong training capabilities.
• Effective organization, communication, and team orientation skills.
• Excellent team players
• Ability to initiate assigned tasks and to work independently.
• Ability to manage multiple projects.
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
  

Travel Requirement:

• Around 50%, within Americas.
  

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com