• Quality Audit Specialist 2 Jobs in United States Of America - 23819374

  • Iqvia
  • United States Of America, Usa

Job Description:

Join us on our exciting journey! IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward

Job Summary

This position is responsible for internal, supplier, client and SOC audits The Quality Auditor initiates and implements quality improvement activities as appropriate to raise performance of the company services, systems and employees; additionally, he/she guides, mentors as well as trains company employees regarding their impact on the QMS and implementation of audit findings and process improvements

Summary of Essential Job Functions

Responsibilities include

Managing and coordinating sponsors audits including quality, privacy, security and 21 CFR Part 11 assessments
Managing and performing internal audits and hosting/supporting client audits
Managing and coordinating preparation for and hosting of SOC 2 Type 2 and client audits
Providing quality oversight for critical business projects including enterprise clients initiatives
Supporting DrugDev/Clintech company-wide Corrective and Preventive Actions (CAPA) program
Consulting project teams on resolution of audit findings, quality management and validation deliverables
Facilitating quality related internal project team meetings and calls
Conducting and supporting calls with customer auditors and quality representatives
Supporting project teams during quality related sponsor meetings and calls
Other duties as assigned


Strong interpersonal and communication skills (both written and verbal)
Understanding clinical trials
Knowledge and experience with 21CFR Part 11 and GXP
Knowledge and experience of Agile SDLC and system validation
Ability to work in a global team environment and excellent problem-solving skills
Focus on quality, results and orientation toward accomplishing strategic organizational goals
Excellent project management skills
Ability to handle multiple, rapidly changing and sometimes conflicting priorities
Prior experience performing client, suppliers and/or internal audits
Prior experience with quality management systems in regulated environment of CRO, pharma and/or medical device companies
High energy, self-starter with the ability to work in a global team environment
Proficiency with MS Word, Excel, and PowerPoint

Minimum Experience Requirements

Bachelors degree in science or business
Graduate Degree preferred
Minimum 5 years of quality, computer systems/software validation, audits and project management experience

Skill Requirements

Strong PC skills (ie Microsoft Office)
Proven organizational skills
Superior interpersonal communication and presentation skills
Comfortable working in a small company environment

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Consulting Services
Functional Area : IT Software : Software Products & Services
Role : Quality Assurance/Testing
Salary : As per Industry Standards
Deadline : 14th Apr 2020

Key Skills:

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