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.
A QA Auditor 2 for Customer Audits for Customer Audits is responsible for hosting customer audits and assisting with regulatory inspections. Managing QA oversight of projects, assignments, and training. Providing consultation in interpretation of regulations, guidelines, policies, and procedures. Providing support to management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures.
Summary of Responsibilities:
- Scheduling, planning, and hosting customer audits.
- Assisting with regulatory facility inspections by serving as a member of the QA Inspection Management Team.
- Maintain customer audit and regulatory inspection tool boxes.
- Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
- Provide consultation to customers, functional leads and monitors in interpretation of audit observations and formulation of corrective action plans.
- Prepare, review and approve corrective action plans
- Present educational programs and provide guidance to operational staff on compliance procedures.
- Conduct 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.
- Serve as author of Quality Assurance SOPs as assigned.
- Lead Projects.
- Train new staff as required.
Required Knowledge, Skills and abilities:
- Practical experience in scheduling, planning, and hosting customer audits.
- Thorough understanding of GCP, PV, and other relevant quality compliance requirements of major regulatory agencies (FDA, EMA, PMDA) and demonstrated experience interpreting and applying relevant regulations, laws and guidance.
- Practical experience applying proactive quality approaches for clinical trials.
Required Education and Experience:
- Bachelors degree in a scientific or healthcare-related field
- Demonstrated experience scheduling, planning, and hosting customer audits
- Minimum 2-3 years of experience in experience in clinical quality in a pharmaceutical, biotech, or other regulated industry.
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@example.com to arrange for such an accommodation.
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