IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
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
- 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
- Bachelor’s degree in science or business
- Graduate Degree preferred
- Minimum 5 years of quality, computer systems/software validation, audits and project management experience
- Strong PC skills (i.e. Microsoft Office)
- Proven organizational skills
- Superior interpersonal communication and presentation skills
- Comfortable working in a small company environment
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [ Email removed ] - URL blocked - click to apply to arrange for such an accommodation.Job ID:
Title 21 Of The Code Of Federal Regulations
Corrective And Preventive Action (Capa)
Process Improvements (Business)
Quality Management Systems