QA Manager (GCP - PV Customer Audits)
Posted on: January 26, 2023
Remote OpportunitySummary:The IQVIA 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, hosting customer audit
and regulatory inspections, 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.Purpose:A QA Manager 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
- 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
- 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 Education and Experience:
- Bachelors degree in a scientific or healthcare-related
- Demonstrated experience scheduling, planning, and hosting
- Minimum 3-5 years of experience in experience in clinical
quality in a pharmaceutical, biotech, Contract Research
Organization or other regulated industry.Required Knowledge, Skills
- Practical experience in scheduling, planning, and hosting
- 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
- Preferred experience in Real Word Data / Real World Evidence,
Computer System Validation and hosting regulatory inspections.
- Preferred experience in GCP, PV and other GxP auditing.
- Tech savvy.Travel:
- Up to 30-40%#LI-Remote #AmberPippinIQVIA 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.comWe are
committed to providing equal employment opportunities for all,
including veterans and candidates with disabilities.
https://jobs.iqvia.com/eoeAs the COVID-19 virus continues to
evolve, IQVIAs ability to operate and provide certain services to
customers and partners necessitates IQVIA and its employees meet
specific requirements regarding vaccination status.
https://jobs.iqvia.com/covid-19-vaccine-statusNew York City Pay
Transparency : The salary range for this role is $95,300 -
$119,100.The actual salary will vary based on factors like
candidate qualifications and competencies.IQVIA is a world leader
in using data, technology, advanced analytics, and expertise to
help customers drive healthcare and human health forward. Together
with the companies we serve, we are enabling a more modern, more
effective and more efficient healthcare system, and creating
breakthrough solutions that transform business and patient
outcomes.To get there, it takes diverse skills and a curiosity to
explore new possibilities. No matter your role, everyone at IQVIA,
including our colleagues at Q Solutions, contributes to our shared
goal of improving human health. Thank you for your interest in
growing your career with us.EEO Minorities/Females/Protected
Keywords: IQVIA, Detroit , QA Manager (GCP - PV Customer Audits), Executive , Detroit, Michigan
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